Labetalol HCL
- Product NDC
- 0615-8131
- 11-digit product format
- 006158131
- Labeler code
- 0615
- Product ID
- 0615-8131_7df47383-03df-4a15-b021-a1d066291c15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA200908
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8131-39 | 00615813139 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8131-39) | 2018-03-02 | 0000-00-00 | No | No | Current |