Labetalol Hydrochloride
- Product NDC
- 0409-0125
- 11-digit product format
- 004090125
- Labeler code
- 0409
- Product ID
- 0409-0125_c1772ea4-65eb-4f27-8e33-3de06278acfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA075240
- Marketing category
- ANDA
- Marketing start
- 2023-08-07
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1GEV3BAW9J | LABETALOL HYDROCHLORIDE | 32780-64-6 | LABETALOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0409-0125-25 | 00409012525 | 25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) | 2023-08-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Labetalol Hydrochloride | Hospira, Inc. | Pfizer Healthcare India Private Limited | 2025-12-10 | HUMAN PRESCRIPTION DRUG LABEL | 28 |