Nalbuphine Hydrochloride
- Product NDC
- 52584-463
- 11-digit product format
- 525840463
- Labeler code
- 52584
- Product ID
- 52584-463_ef7d41c3-d6a5-40aa-b920-9e2e25d4a8f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nalbuphine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- General Injectables & Vaccines, Inc
- Application
- ANDA070914
- Marketing category
- ANDA
- Marketing start
- 2010-03-01
- Marketing end
- 2023-09-01
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-463-01 | 52584046301 | 1 AMPULE in 1 BAG (52584-463-01) > 1 mL in 1 AMPULE | 1 ampule | 2010-03-01 | 0000-00-00 | No | No | Current |