Generic News 9.29.14

Author: APCI Staff/Monday, September 29, 2014/Categories: Generic Bulletins

Critical to Know

OneStop Product Announcement | DEA Controls Hydrocodone Combination Products as Schedule II Controlled Substance

Effective October 6, 2014, Hydrocodone Combination Products (HCPs) will be rescheduled from Schedule III to Schedule II. This change is being made by the DEA due to abuse and diversion concerns.

Pharmacists should manage their pharmacy handling, storage and ordering of HCPs carefully as the effective date for rescheduling approaches – particularly if the pharmacy is ineligible to dispense CII controlled substances.

Below please find detailed information regarding important dates to be aware and process and procedures to consider. In addition, please click here for a list of frequently asked questions for your reference.


What You Should Do Next


Take action to prepare for the following key dates:


  • By September 29, 2014:
    • Returns: Per the DEA, pharmacies may continue to dispense CIII labeled HCP until such inventory is depleted. Therefore, there is no need to return CIII labeled product. The CIII labeled HCPs are NOT being recalled.
      • If you are planning on returning any CIII labeled HCPs, the last day to request a Return Authorization from McKesson is September 29th.
      • After September 29th, all returns for CIII labeled HCP will be blocked.
      • All CIII labeled HCP returns must be received at the distribution center by October 3rd, NO EXCEPTIONS.
      • Pharmacies ineligible to store/dispense CII controlled substances should return their CIII labeled HCP  inventory to McKesson in accordance with these dates.
  • October 2, 2014:
    • Last day to order CIII labeled HCP from McKesson.
  • October 3, 2014:
    • Last delivery day for  CIII labeled HCPs ordered by October 2, 2014.
    • Last day for distribution centers to receive CIII labeled HCP returns.
  • October 3-5, 2014: Blackout Period; HCP (CII or CIII) unavailable for order.
  • October 6, 2014: Effective date for HCP rescheduling to CII
    • First day to order CII labeled HCPs.
    • As of this date, HCPs distributed by McKesson will be labeled as CII.
    • All CII labeled HCPs will have a new McKesson item number. Please see the attached document for the new items numbers. NOTE: Remember to update your maintenance to reflect the new item numbers.
    • All HCP inventory, regardless of labeling, should be managed, stored, handled and dispensed as a CII controlled substance going forward.
  • October 7, 2014: First delivery day for CII labeled HCP ordered on October 6, 2014.

McKesson Points of Contact

Please reach out to your McKesson sales representative for support if you have any questions.  

Helpful Tools and Resources

  • Refer to attached list of Frequently Asked Questions (FAQs).
  • Refer to the attachment for the New Item Number Conversion Table
  • The final federal ruling has been published online for your reference
  • To facilitate ordering of CII substances, pharmacies should either be enrolled in the DEA's Controlled Substance Ordering System (CSOS) or stock up on the DEA Form 222.

Service Levels

Availability on Top Service Level Issue Products


Bupropion HCl extended release tablets from Par and American Health available now.

Item # NDC # Item Description Item Status
1760859 10370010203 BUPROPIO ER TAB 300MG ANCH 30 Inventory available
1764158 68084025221 BUPROPIO ER TB 300MG UD AHP30 Inventory available
1761345 10370010250 BUPROPIO ER TAB 300MG ANCH500 Inventory available

Butalbital, Acetaminophen and Caffeine tablets from Qualitest available now.

Item # NDC # Item Description Item Status
1277342 00603254421 BUT + AP + CAF TB 325-40-50 Q/P1C Inventory available
1278456 00603254428 BUT + AP + CAF TB 325-40-50 Q/P5C Inventory available
1950740 00603254432 BUT + AP + CAF TB50/325/40Q/P1000 Inventory available in the alternate choice (A/C) slot

Divalproex Sodium tablets from Caraco available late September or have no anticipated availability date.

Item # NDC # Item Description Item Status
1707827 62756079688 DIVALP DR TB 125MG CARA 100 No anticipated availability date
1707975 62756079788 DIVALP DR TB 250MG CARA 100 Inventory available late September
1708106 62756079888 DIVALP DR TB 500MG CARA 100 Inventory available late September
1708049 62756079713 DIVALP DR TB 250MG CARA 500 No anticipated availability date
1708122 62756079813 DIVALP DR TB 500MG CARA 500 No anticipated availability date

Fluoxetine HCl capsules from Aurobindo available now and early October.

Item # NDC # Item Description Item Status
1123694 65862019201 FLUOXET CAP 10MG AURO 100 Inventory available
3600152 65862019299 FLUOXET CAP 10MG AURO 1000 Inventory available early October

Hydroxychloroquine Sulfate tablets from Mylan available now; tables from Ranbaxy and American Health have no anticipated availability date.

Item # NDC # Item Description Item Status
1195353 00378037301 HYDROXYCH TAB 200MG MYL 100 Inventory available
1793918 63304029601 HYDROXYCH TAB 200MG RAN 100 No anticipated availability date
1794866 63304029605 HYDROXYCH TAB 200MG RAN 500 No anticipated availability date
1713528 68084026901 HYDROXYCH TB 200MG UD AHP 100 No anticipated availability date
1713528 68084026901 HYDROXYCH TB 200MG UD AHP 100 No anticipated availability date

Ketoconazole cream from Sandoz available early October.

Item # NDC # Item Description Item Status
1273325 00168009915 KETOCONAZOLE CRM 2% FOUG 15GM Inventory available early October
1273507 00168009930 KETOCONAZOLE CRM 2% FOUG 30GM Inventory available early October
1267152 00168009960 KETOCONAZOLE CRM 2% FOUG 60GM Inventory available early October

Lisinopril tablets from Qualitest have no anticipated availability date; tablets from Sandoz available as backup and SKY unit dose tablets available now.

Item # NDC # Item Description Item Status
1987007 00603421221 LISINOPR TAB 20MG Q/P 100 No anticipated availability date
1254200 63739035010 LISINOPR TB 20MG UD SKY 10X10 Inventory available
1248962 00603421228 LISINOPR TAB 20MG Q/P 500 No anticipated availability date
1987015 00603421232 LISINOPR TAB 20MG Q/P 1000 No anticipated availability date
2121440 00185010210 LISINOPR TAB 20MG SAN 1000 Inventory available in the backup (B) slot

Losartan Potassium tablets from Aurobindo available now and early October.

Item # NDC # Item Description Item Status
1979079 65862020330 LOSARTAN POT TAB 100MG AURO30 Inventory available at limited DCs
1936905 65862020390 LOSART POT TAB 100MG AURO 90 Inventory available
1979087 65862020399 LOSARTAN POT TAB 100MG AURO1M Inventory available early October

Metoprolol Succinate extended release tablets from Mylan on intermittent backorder; tablets from Dr Reddy and American Health available now.

Item # NDC # Item Description Item Status
2233955 00378459677 METOPROL ER TAB 50MG MYLN 90 Intermittent backorder
1779040 55111046701 METOPROL ER TAB 50MG DR/R 100 Inventory available
2065548 68084066601 METOPROL ER TB 50MG UD AHP100 Inventory available
1779057 55111046705 METOPROL ER TAB 50MG DR/R 500 Inventory available

Metoprolol Tartrate tablets from Caraco available now and early October; tablets from Mylan available now.

Item # NDC # Item Description Item Status
1914373 57664050658 METOPROL TRT TB 25MG CAR 1000 Inventory available early October
1199850 00378001801 METOPROL TRT TB 25MG MYL 100 Inventory available
1914365 57664050652 METOPROL TRT TB 25MG CARA 100 Inventory available in the alternate choice (A/C) slot
3219383 00378001805 METOPROL TRT TB 25MG MYLN 500 Inventory available in the alternate choice (A/C) slot

Mupirocin Calcium cream from Prasco available now and early October.

Item # NDC # Item Description Item Status
1902840 66993094215 MUPIROCIN CM 2% PRAS 15G Inventory available
1902857 66993094231 MUPIROCIN CM 2% PRAS 30G Inventory available early October

Omega-3 Acid Ethyl Esters capsules from Teva available late September as an alternate choice.

Item # NDC # Item Description Item Status
2026623 00093540189 OMEGA-3 ACD ETH CP 1GM TEV120 Inventory available late September in the alternate choice (A/C) slot

See below for availability of Potassium Chloride extended release tablets from Sandoz, American Health, and SKY .

Item # NDC # Item Description Item Status
1486042 00781571001 POT CHL ER TAB 10MEQ SAN 100 Inventory available early October
1131911 63739044610 POT CHL ER TB 10MEQ UD SKY100 Inventory available in the alternate choice (A/C) slot
2016327 68084063201 POT CHL ER TB 10MEQ UD AHP100 Inventory available at limited DCs in the alternate choice (A/C) slot
1488048 00781571010 POT CHL ER TAB 10MEQ SAN 1000 Inventory available in the alternate choice (A/C) slot

Risperidone tablets from Qualitest have no anticipated availability date; tablets from Patriot and American Health available now as an alternate choice.

Item # NDC # Item Description Item Status
1137702 00603568420 RISPERID TAB 0.5MG Q/P 60 No anticipated availability date
1752245 50458059160 RISPERID TB 0.5MG PATR 60 Inventory available in the alternate choice (A/C) slot
1752765 50458059110 RISPERID TB 0.5MG UD PATR 100 Inventory available
3247509 68084027101 RISPERID TAB 0.5MG UD AHP 100 Inventory available at limited DCs in the alternate choice (A/C) slot
1137751 00603568428 RISPERID TAB 0.5MG Q/P 500 No anticipated availability date
1753656 50458059150 RISPERID TB 0.5MG PATR 500 Inventory available at limited DCs in the alternate choice (A/C) slot

Product List and additional information is available on McK Connect as well APCINET.com Please contact your McKesson ISM or RSM should you need assistance.

APCI Vendor Updates:

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