Buprenorphine HCl
- Product NDC
- 67296-2123
- 11-digit product format
- 672962123
- Labeler code
- 67296
- Product ID
- 67296-2123_4698a89b-6565-4e29-e063-6394a90aaf22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine HCl
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Redpharm Drug
- Application
- ANDA078633
- Marketing category
- ANDA
- Marketing start
- 2009-10-08
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buprenorphine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 351264 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-2123-3 | Buprenorphine HCl | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-2123 | BUPRENORPHINE HCL TABLET [REDPHARM DRUG] | 1 | Current NDC, 1 package rows | 20250313_301eaed5-8499-ad95-e063-6294a90a58f5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-2123-3 | 67296212303 | 30 TABLET in 1 BOTTLE (67296-2123-3) | 30 tablet | 2009-10-08 | No | No | Historical |