Naltrexone Hydrochloride
- Product NDC
- 68094-909
- 11-digit product format
- 680940909
- Labeler code
- 68094
- Product ID
- 68094-909_efc0724d-4c6e-4974-928c-fd50774f5980
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Precision Dose Inc.
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- Marketing end
- 2028-06-30
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z6375YW9SF |
| Rxcui | 1483744 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-909-30 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 68094-909-50 | Naltrexone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-909 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 2 | Current NDC, 2 package rows | 20240215_b09b4b5e-795a-48e7-b7cc-2e29f41c5660.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68094-909-30 | 68094090930 | 30 TABLET, FILM COATED in 1 BOTTLE (68094-909-30) | 2024-02-15 | 2028-06-30 | No | No | Historical |
| 68094-909-50 | 68094090950 | 100 TABLET, FILM COATED in 1 BOTTLE (68094-909-50) | 2024-02-15 | 2028-06-30 | No | No | Historical |