Buprenorphine and Naloxone
- Product NDC
- 31722-479
- 11-digit product format
- 317220479
- Labeler code
- 31722
- Product ID
- 31722-479_fc47f8e4-395a-4030-b9fb-71ba779479bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine and naloxone
- Dosage form
- FILM, SOLUBLE
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA219850
- Marketing category
- ANDA
- Marketing start
- 2026-05-01
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 2; .5 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 | 2 mg/1 |
| NALOXONE HYDROCHLORIDE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR, 56W8MW3EN1 |
| Rxcui | 1010600, 1010604, 1307056, 1307061 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-479-30 | Buprenorphine and Naloxone | 30 in 1 CARTON | FILM, SOLUBLE | 30 | | 1 |
| 31722-479-31 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM, SOLUBLE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-479-30 | 31722047930 | 30 POUCH in 1 CARTON (31722-479-30) / 1 FILM, SOLUBLE in 1 POUCH (31722-479-31) | 30 pouch | 2026-05-01 | No | No | Historical |
| 31722-479-31 | 31722047931 | 1 in 1 POUCH | | | | | Historical |