Buprenorphine and Naloxone
- Product NDC
- 60687-626
- 11-digit product format
- 606870626
- Labeler code
- 60687
- Product ID
- 60687-626_202259e2-8dae-1a15-e063-6394a90a1020
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- American Health Packaging
- Application
- ANDA205601
- Marketing category
- ANDA
- Marketing start
- 2022-03-10
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- 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 HYDROCHLORIDE | 2 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5Q187997EE, 56W8MW3EN1 |
| Rxcui | 351266, 351267 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-626-11 | Buprenorphine and Naloxone | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
| 60687-626-65 | Buprenorphine and Naloxone | 50 in 1 CARTON | TABLET | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-626 | BUPRENORPHINE AND NALOXONE TABLET [AMERICAN HEALTH PACKAGING] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240822_b05b0087-c0ef-40be-9bf3-3933f6cd3492.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 |
|---|
| 60687-626-11 | 60687062611 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 60687-626-65 | 60687062665 | 50 BLISTER PACK in 1 CARTON (60687-626-65) / 1 TABLET in 1 BLISTER PACK (60687-626-11) | 50 blister pack | 2022-03-10 | 0000-00-00 | No | No | Current |