Naltrexone Hydrochloride
- Product NDC
- 70518-1146
- 11-digit product format
- 705181146
- Labeler code
- 70518
- Product ID
- 70518-1146_ef694a28-dc11-3786-e053-2a95a90a6d91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA091205
- Marketing category
- ANDA
- Marketing start
- 2018-04-27
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1146 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 14 | Legacy NDC | 20250507_7e126353-8d94-4163-b7f5-dc7c47e685b2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1146-0 | 70518114600 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1146-0) | 2018-04-27 | 0000-00-00 | No | No | Current |