FDA National Drug Codes
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FDA National Drug Codes
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FDA National Drug Codes
Browse every product in the FDA NDC Directory below, or search by NDC, brand, generic, manufacturer or HCPCS code. Each product has its own page with package NDCs in 11-digit billing format.
6,555 products (finished products)
| Product | Strength | Form · route | Labeler | Application | Product NDC | Package NDCs (11-digit) | HCPCS |
|---|---|---|---|---|---|---|---|
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Bryant Ranch Prepack | ANDA | 72162-1345 | 72162-1345-0072162-1345-0272162-1345-03+6 more | — |
| Buprenorphine | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | ANDA | 87441-011 | 87441-0011-01 | — |
| Buprenorphine | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Unit Dose Solutions, Inc. | ANDA | 87441-082 | 87441-0082-01 | — |
| buprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual |
| Hikma Pharmaceuticals USA Inc. |
| ANDA |
| 0054-0188 |
| 00054-0188-13 |
| — |
| buprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | ANDA | 0054-0189 | 00054-0189-13 | — |
|---|
| Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochloride | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | ANDA | 0121-1018 | 00121-1018-30 | — |
|---|
| Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochloride | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | ANDA | 0121-2036 | 00121-2036-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Actavis Pharma, Inc. | ANDA | 0228-3154 | 00228-3154-03 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Actavis Pharma, Inc. | ANDA | 0228-3155 | 00228-3155-03 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | FilmBuccal, Sublingual | Mylan Pharmaceuticals Inc. | ANDA | 0378-8765 | 00378-8765-93 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride dihydrate 1 mg/1 | FilmBuccal, Sublingual | Mylan Pharmaceuticals Inc. | ANDA | 0378-8766 | 00378-8766-93 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | FilmBuccal, Sublingual | Mylan Pharmaceuticals Inc. | ANDA | 0378-8767 | 00378-8767-93 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride dihydrate 3 mg/1 | FilmBuccal, Sublingual | Mylan Pharmaceuticals Inc. | ANDA | 0378-8768 | 00378-8768-93 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | Film, SolubleBuccal, Sublingual | Camber Pharmaceuticals, Inc. | ANDA | 31722-479 | 31722-0479-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1 | Film, SolubleBuccal, Sublingual | Camber Pharmaceuticals, Inc. | ANDA | 31722-480 | 31722-0480-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | Film, SolubleBuccal, Sublingual | Camber Pharmaceuticals, Inc. | ANDA | 31722-481 | 31722-0481-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1 | Film, SolubleBuccal, Sublingual | Camber Pharmaceuticals, Inc. | ANDA | 31722-482 | 31722-0482-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Camber Pharmaceuticals, Inc. | ANDA | 31722-850 | 31722-0850-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Camber Pharmaceuticals, Inc. | ANDA | 31722-851 | 31722-0851-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | ANDA | 3215-6521 | 03215-6521-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | ANDA | 3215-6522 | 03215-6522-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | ANDA | 3215-6523 | 03215-6523-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1 | FilmBuccal, Sublingual | Aveva Drug Delivery Systems Inc. | ANDA | 3215-6524 | 03215-6524-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Rhodes Pharmaceuticals LLC | ANDA | 42858-601 | 42858-0601-03 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Rhodes Pharmaceuticals LLC | ANDA | 42858-602 | 42858-0602-03 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone .5 mg/1 | Film, SolubleBuccal, Sublingual | Dr.Reddys Laboratories Inc | ANDA | 43598-579 | 43598-0579-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone 1 mg/1 | Film, SolubleBuccal, Sublingual | Dr.Reddys Laboratories Inc | ANDA | 43598-580 | 43598-0580-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone 3 mg/1 | Film, SolubleBuccal, Sublingual | Dr.Reddys Laboratories Inc | ANDA | 43598-581 | 43598-0581-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone 2 mg/1 | Film, SolubleBuccal, Sublingual | Dr.Reddys Laboratories Inc | ANDA | 43598-582 | 43598-0582-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | FilmBuccal, Sublingual | INGENUS PHARMACEUTICALS, LLC | ANDA | 50742-364 | 50742-0364-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1 | FilmBuccal, Sublingual | INGENUS PHARMACEUTICALS, LLC | ANDA | 50742-365 | 50742-0365-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | FilmBuccal, Sublingual | INGENUS PHARMACEUTICALS, LLC | ANDA | 50742-397 | 50742-0397-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1 | FilmBuccal, Sublingual | INGENUS PHARMACEUTICALS, LLC | ANDA | 50742-398 | 50742-0398-30 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | American Health Packaging | ANDA | 60687-626 | 60687-0626-65 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | American Health Packaging | ANDA | 60687-637 | 60687-0637-65 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine 2 mg/1; Naloxone .5 mg/1 | TabletSublingual | Lannett Company, Inc. | ANDA | 62175-452 | 62175-0452-32 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine 8 mg/1; Naloxone 2 mg/1 | TabletSublingual | Lannett Company, Inc. | ANDA | 62175-458 | 62175-0458-32 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Sun Pharmaceutical Industries, Inc. | ANDA | 62756-969 | 62756-0969-6462756-0969-83 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Sun Pharmaceutical Industries, Inc. | ANDA | 62756-970 | 62756-0970-6462756-0970-83 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | ANDA | 63629-9482 | 63629-9482-01 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | ANDA | 63629-9483 | 63629-9483-01 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | FilmBuccal, Sublingual | Redpharm Drug | ANDA | 67296-2063 | 67296-2063-0367296-2063-06 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Redpharm Drug | ANDA | 67296-2164 | 67296-2164-0167296-2164-06 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | FilmBuccal, Sublingual | Redpharm Drug | ANDA | 67296-2228 | 67296-2228-0167296-2228-03 | — |
|---|
| Buprenorphine And Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | TabletSublingual | Ascend Laboratories, LLC | ANDA | 67877-606 | 67877-0606-3067877-0606-8467877-0606-90 | — |
|---|
| Buprenorphine And Naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 | TabletSublingual | Ascend Laboratories, LLC | ANDA | 67877-607 | 67877-0607-3067877-0607-8467877-0607-90 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | ANDA | 70518-3389 | 70518-3389-00 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine 2 mg/1; Naloxone .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | ANDA | 71335-1296 | 71335-1296-0171335-1296-02 | — |
|---|
| Buprenorphine and Naloxone | Buprenorphine 8 mg/1; Naloxone 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | ANDA | 71335-1378 | 71335-1378-0071335-1378-0171335-1378-02+7 more | — |
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| Buprenorphine and Naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Bryant Ranch Prepack | ANDA | 71335-2828 | 71335-2828-01 | — |
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