Labetalol Hydrochloride
- Product NDC
- 23155-726
- 11-digit product format
- 231550726
- Labeler code
- 23155
- Product ID
- 23155-726_50a37968-605e-481b-af03-db963542a6c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA074787
- Marketing category
- ANDA
- Marketing start
- 2026-05-15
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-726-01 | 23155072601 | 100 TABLET in 1 BOTTLE (23155-726-01) | 100 tablet | 2026-05-15 | No | No | Historical |
| 23155-726-05 | 23155072605 | 500 TABLET in 1 BOTTLE (23155-726-05) | 500 tablet | 2026-05-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Labetalol Hydrochloride Tablets, USP Rx only | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 2026-03-05 | HUMAN PRESCRIPTION DRUG LABEL | 6 |