Buprenorphine
- Product NDC
- 0228-3156
- 11-digit product format
- 002283156
- Labeler code
- 0228
- Product ID
- 0228-3156_eb9e7c72-45fb-4455-a405-027cf06caac6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA090819
- Marketing category
- ANDA
- Marketing start
- 2015-02-19
- 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 |
|---|
| 0228-3156-03 | Buprenorphine | 30 in 1 BOTTLE | TABLET | 30 | | 34 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPRENORPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | 56W8MW3EN1 | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| BUPRENORPHINE | ACTIVE MOIETY | 40D3SCR4GZ | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-3156 | BUPRENORPHINE TABLET [ACTAVIS PHARMA, INC.] | 32 | Current NDC, Legacy NDC, 1 package rows | 20250416_03819118-86f6-4329-adaf-4599e7b71f46.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 |
|---|
| 0228-3156-03 | 00228315603 | 30 TABLET in 1 BOTTLE (0228-3156-03) | 30 tablet | 2015-04-10 | 0000-00-00 | No | No | Current |