Nalbuphine Hydrochloride
- Product NDC
- 0404-9917
- 11-digit product format
- 004049917
- Labeler code
- 0404
- Product ID
- 0404-9917_4b5297a9-e4da-4412-b649-ea0cc3b810f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nalbuphine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA070918
- Marketing category
- ANDA
- Marketing start
- 2022-01-13
- Marketing end
- 0000-00-00
- Substance
- NALBUPHINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [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 |
|---|
| 0404-9917 | NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Legacy NDC | 20241122_80e454d8-06ac-454e-af1e-c01452b285e7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9917-10 | 00404991710 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9917-10) > 10 mL in 1 VIAL, MULTI-DOSE | 2022-01-13 | 0000-00-00 | No | No | Current |