Labetalol Hydrochloride
- Product NDC
- 63629-1165
- 11-digit product format
- 636291165
- Labeler code
- 63629
- Product ID
- 63629-1165_e4972845-be4c-448e-bbac-874f371b034c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075215
- Marketing category
- ANDA
- Marketing start
- 2019-11-22
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-1165-1 | 63629116501 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-1165-1) | 2019-11-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Labetalol HCl Tablets | Bryant Ranch Prepack | 2024-08-20 | HUMAN PRESCRIPTION DRUG LABEL | 105 |