Labetalol Hydrochloride
- Product NDC
- 0615-8512
- 11-digit product format
- 006158512
- Labeler code
- 0615
- Product ID
- 0615-8512_7af3cd76-a5ca-406d-9455-d442f8d658d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- 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
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 | Sample | Exclude flag | Status |
|---|
| 0615-8512-39 | 00615851239 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8512-39) | 2024-06-14 | No | No | Historical |