Labetalol Hydrochloride
- Product NDC
- 71335-2923
- 11-digit product format
- 713352923
- Labeler code
- 71335
- Product ID
- 71335-2923_4253f872-d7db-c83c-e063-6394a90a90f8
- 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
- 200 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 |
|---|
| 71335-2923-1 | 71335292301 | 500 TABLET, FILM COATED in 1 BOTTLE (71335-2923-1) | 2025-10-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Labetalol HCl Tablets | Bryant Ranch Prepack | 2025-10-29 | HUMAN PRESCRIPTION DRUG LABEL | 100 |