Labetalol hydrochloride
- Product NDC
- 50090-7156
- 11-digit product format
- 500907156
- Labeler code
- 50090
- Product ID
- 50090-7156_600f7629-8912-496d-872b-753dcdea425a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA075133
- Marketing category
- ANDA
- Marketing start
- 1998-08-03
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Labetalol hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LABETALOL HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
DailyMed Product Concepts#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7156-0 | 50090715600 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-0) | 2024-04-30 | No | No | Current |
| 50090-7156-1 | 50090715601 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-1) | 2024-04-30 | No | No | Current |