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
- 2026-12-31
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 |
| Rxcui | 351266 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
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 |