Labetalol Hydrochloride
- Product NDC
- 63629-2054
- 11-digit product format
- 636292054
- Labeler code
- 63629
- Product ID
- 63629-2054_a42669d6-2662-4689-bfe7-d8e1034005ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207863
- Marketing category
- ANDA
- Marketing start
- 2019-05-24
- Substance
- LABETALOL HYDROCHLORIDE
- 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 |
|---|
| 1GEV3BAW9J | LABETALOL HYDROCHLORIDE | 32780-64-6 | LABETALOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-2054-1 | 63629205401 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-2054-1) | 2021-01-26 | No | No | Historical |