Naltrexone
- Product NDC
- 69238-2794
- 11-digit product format
- 692382794
- Labeler code
- 69238
- Product ID
- 69238-2794_eb09c632-ad0b-4dc9-b7a6-3189ba25f77e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone
- Dosage form
- KIT
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- NDA021897
- Marketing category
- NDA
- Marketing start
- 2026-05-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 637213 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-2792-1 | Naltrexone | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, FOR SUSPENSIO | 5 mL | 380 mg in 5mL | 1 |
| 69238-2794-1 | Naltrexone | 1 in 1 CARTON | KIT | 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 |
|---|
| 69238-2792-1 | 69238279201 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | Historical |
| 69238-2794-1 | 69238279401 | 1 KIT in 1 CARTON (69238-2794-1) * 5 mL in 1 VIAL, GLASS (69238-2792-1) * 4 mL in 1 VIAL, GLASS (69238-2793-1) | 1 kit | 2026-05-01 | No | No | Historical |