Buprenorphine and Naloxone
- Product NDC
- 62756-970
- 11-digit product format
- 627560970
- Labeler code
- 62756
- Product ID
- 62756-970_cbeda871-3722-4395-a97f-b614b5406675
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201633
- Marketing category
- ANDA
- Marketing start
- 2017-07-18
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 8; 2 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
- 2027-12-31
- 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 HYDROCHLORIDE | 8 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
| Rxcui | 351266, 351267 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-970-64 | Buprenorphine and Naloxone | 3 in 1 CARTON | TABLET | 3 | | 33 |
| 62756-970-64 | Buprenorphine and Naloxone | 10 in 1 BLISTER PACK | TABLET | 10 | | 33 |
| 62756-970-83 | Buprenorphine and Naloxone | 30 in 1 BOTTLE | TABLET | 30 | | 33 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-970 | BUPRENORPHINE AND NALOXONE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 29 | Current NDC, Legacy NDC, 3 package rows | 20231107_91b68606-05de-4586-ae31-07e8cc9160cf.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 |
|---|
| 62756-970-64 | 62756097064 | 3 BLISTER PACK in 1 CARTON (62756-970-64) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2017-07-18 | 0000-00-00 | No | No | Current |
| 62756-970-83 | 62756097083 | 30 TABLET in 1 BOTTLE (62756-970-83) | 30 tablet | 2017-07-18 | 0000-00-00 | No | No | Current |