NALTREXONE HYDROCHLORIDE
- Product NDC
- 76519-1160
- 11-digit product format
- 765191160
- Labeler code
- 76519
- Product ID
- 76519-1160_5f256d4f-450a-87c7-e053-2a91aa0a79ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALTREXONE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H.J. Harkins Company Inc.
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2017-10-17
- Marketing end
- 0000-00-00
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76519-1160-5 | NALTREXONE HYDROCHLORIDE | 15 in 1 CONTAINER | TABLET, FILM COATED | 15 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1160 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY INC.] | 1 | Legacy NDC, 1 package rows | 20171201_5f256d4f-4509-87c7-e053-2a91aa0a79ef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1160-5 | 76519116005 | 15 in 1 CONTAINER | Historical |