LABETALOL HYDROCHLORIDE
- Product NDC
- 70121-2428
- 11-digit product format
- 701212428
- Labeler code
- 70121
- Product ID
- 70121-2428_1878c304-0b8f-402d-8dd1-7d6be6108d07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- labetalol hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA218870
- Marketing category
- ANDA
- Marketing start
- 2025-10-02
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-2428-3 | 70121242803 | 24 CARTON in 1 CARTON (70121-2428-3) / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1) / 4 mL in 1 SYRINGE, GLASS | 24 carton | 2025-10-02 | No | No | Historical |