Buprenorphine
- Product NDC
- 58118-4459
- 11-digit product format
- 581184459
- Labeler code
- 58118
- Product ID
- 58118-4459_2e5a8bb5-e89c-7e3e-e063-6294a90a6b18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Clinical Solutions Wholesale, LLC
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buprenorphine
- 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 |
|---|
| 58118-4459-8 | Buprenorphine | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58118-4459 | BUPRENORPHINE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | Current NDC, 1 package rows | 20250221_9d976ee7-9509-49da-89fd-48d7e712697b.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 |
|---|
| 58118-4459-8 | 58118445908 | 30 TABLET in 1 BLISTER PACK (58118-4459-8) | 30 tablet | 2025-02-17 | No | No | Current |