Buprenorphine
- Product NDC
- 62756-459
- 11-digit product format
- 627560459
- Labeler code
- 62756
- Product ID
- 62756-459_ba293490-0f6f-4400-82cd-3af9774839e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201760
- Marketing category
- ANDA
- Marketing start
- 2016-02-17
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 351264, 351265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-459-64 | Buprenorphine | 3 in 1 CARTON | TABLET | 3 | | 32 |
| 62756-459-64 | Buprenorphine | 10 in 1 BLISTER PACK | TABLET | 10 | | 32 |
| 62756-459-83 | Buprenorphine | 30 in 1 BOTTLE | TABLET | 30 | | 32 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-459 | BUPRENORPHINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 28 | Current NDC, Legacy NDC, 3 package rows | 20231122_9fd1f18f-0b0f-4059-b603-19ecbf0ed63a.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 |
|---|
| 62756-459-64 | 62756045964 | 3 BLISTER PACK in 1 CARTON (62756-459-64) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2016-02-17 | 0000-00-00 | No | No | Current |
| 62756-459-83 | 62756045983 | 30 TABLET in 1 BOTTLE (62756-459-83) | 30 tablet | 2016-02-17 | 0000-00-00 | No | No | Current |