Buprenorphine and Naloxone
- Product NDC
- 0228-3155
- 11-digit product format
- 002283155
- Labeler code
- 0228
- Product ID
- 0228-3155_f8429e6b-f73d-4f29-8e2e-f8910cfba41d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA091422
- Marketing category
- ANDA
- Marketing start
- 2013-03-04
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 8; 2 mg/1; mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA], 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 and Naloxone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
| Rxcui | 351266, 351267 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-3155-03 | Buprenorphine and Naloxone | 30 in 1 BOTTLE | TABLET | 30 | | 49 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPRENORPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | 56W8MW3EN1 | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| NALOXONE HYDROCHLORIDE DIHYDRATE | ACTIVE INGREDIENT | 5Q187997EE | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| BUPRENORPHINE | ACTIVE MOIETY | 40D3SCR4GZ | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| NALOXONE | ACTIVE MOIETY | 36B82AMQ7N | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-3155 | BUPRENORPHINE AND NALOXONE TABLET [ACTAVIS PHARMA, INC.] | 44 | Current NDC, Legacy NDC, 1 package rows | 20250406_6cccf229-9611-4b6f-8f1b-acc8ff1ed3f8.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 |
|---|
| 0228-3155-03 | 00228315503 | 30 TABLET in 1 BOTTLE (0228-3155-03) | 30 tablet | 2013-03-04 | 0000-00-00 | No | No | Current |
| 0228-3155-73 | 00228315573 | 2 BLISTER PACK in 1 CARTON (0228-3155-73) > 15 TABLET in 1 BLISTER PACK (0228-3155-67) | 2 blister pack | 2015-10-01 | 2021-02-28 | No | No | Current |