Buprenorphine
- Product NDC
- 0054-0176
- 11-digit product format
- 000540176
- Labeler code
- 0054
- Product ID
- 0054-0176_e59c3c4f-a9cc-412b-b001-b9e430f537c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- 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
- 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 |
|---|
| 0054-0176-13 | Buprenorphine | 30 in 1 BOTTLE | TABLET | 30 | | 32 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPRENORPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | 56W8MW3EN1 | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| BUPRENORPHINE | ACTIVE MOIETY | 40D3SCR4GZ | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0176 | BUPRENORPHINE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 27 | Current NDC, Legacy NDC, 1 package rows | 20250514_1bf8b35a-b769-465c-a2f8-099868dfcd2f.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 |
|---|
| 0054-0176-13 | 00054017613 | 30 TABLET in 1 BOTTLE (0054-0176-13) | 30 tablet | 2009-10-08 | 0000-00-00 | No | No | Current |