Labetalol Hydrochloride
- Product NDC
- 58657-908
- 11-digit product format
- 586570908
- Labeler code
- 58657
- Product ID
- 58657-908_46b55541-52d5-7213-e063-6294a90affc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA075215
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- LABETALOL
- Active strength
- 300 mg/1
- 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 |
|---|
| R5H8897N95 | LABETALOL | 36894-69-6 | LABETALOL |
| 1GEV3BAW9J | LABETALOL HYDROCHLORIDE | 32780-64-6 | Labetalol Hydrochloride |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58657-908-01 | 58657090801 | 100 BLISTER PACK in 1 CARTON (58657-908-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (58657-908-10) | 100 blister pack | 2025-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Labetalol Hydrochloride | Method Pharmaceuticals, LLC | 2025-12-23 | HUMAN PRESCRIPTION DRUG LABEL | 11 |