LABETALOL HYDROCHLORIDE
- Product NDC
- 60760-784
- 11-digit product format
- 607600784
- Labeler code
- 60760
- Product ID
- 60760-784_ed2293f8-2b83-c3db-e053-2995a90ad46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA211953
- Marketing category
- ANDA
- Marketing start
- 2022-10-25
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 100 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 |
|---|
| LABETALOL HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 60760-784-90 | 60760078490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-784-90) | 2022-10-25 | 0000-00-00 | No | No | Current |