Nalbuphine Hydrochloride
- Product NDC
- 52584-464
- 11-digit product format
- 525840464
- Labeler code
- 52584
- Product ID
- 52584-464_68ac3098-5f7b-4d96-8a33-940f3d016f3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nalbuphine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA070915
- Marketing category
- ANDA
- Marketing start
- 2021-04-19
- Marketing end
- 2023-07-01
- Substance
- NALBUPHINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-464-61 | 52584046461 | 1 VIAL, MULTI-DOSE in 1 BAG (52584-464-61) > 10 mL in 1 VIAL, MULTI-DOSE | 2021-04-19 | 0000-00-00 | No | No | Current |