buprenorphine hydrochloride
- Product NDC
- 50090-7559
- 11-digit product format
- 500907559
- Labeler code
- 50090
- Product ID
- 50090-7559_18fa8a54-6196-4635-a213-f78a9236f3d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090622
- Marketing category
- ANDA
- Marketing start
- 2023-10-12
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 8 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 hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 351265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7559-0 | buprenorphine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7559 | BUPRENORPHINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20250529_c1398d85-d4bb-4426-8ecf-a50400910d81.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 |
|---|
| 50090-7559-0 | 50090755900 | 30 TABLET in 1 BOTTLE (50090-7559-0) | 30 tablet | 2025-05-27 | No | No | Historical |