Buprenorphine and Naloxone
- Product NDC
- 71335-1296
- 11-digit product format
- 713351296
- Labeler code
- 71335
- Product ID
- 71335-1296_9edc1edc-dc15-456c-b48f-aebe63540b31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205022
- Marketing category
- ANDA
- Marketing start
- 2016-09-19
- Substance
- BUPRENORPHINE; NALOXONE
- Active strength
- 2; .5 mg/1; mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buprenorphine and Naloxone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE | 2 mg/1 |
| NALOXONE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 40D3SCR4GZ, 36B82AMQ7N |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1296-1 | 2024-05-22 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
| 71335-1296-1 | 2024-05-22 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
| 71335-1296-2 | 2024-05-22 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
| 71335-1296-2 | 2024-05-22 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
| 71335-1296-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
| 71335-1296-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
| 71335-1296-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
| 71335-1296-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-34ef-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1296-1 | Buprenorphine and Naloxone | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 71335-1296-2 | Buprenorphine and Naloxone | 10 in 1 BOTTLE | TABLET | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1296 | BUPRENORPHINE AND NALOXONE TABLET [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240522_fc2755a5-3292-4b49-872d-e22c386a4e44.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1296-1 | 71335129601 | 30 TABLET in 1 BOTTLE (71335-1296-1) | 30 tablet | 2019-08-12 | 0000-00-00 | No | No | Current |
| 71335-1296-2 | 71335129602 | 10 TABLET in 1 BOTTLE (71335-1296-2) | 10 tablet | 2024-05-17 | 0000-00-00 | No | No | Current |