Labetalol Hydrochloride
- Product NDC
- 63629-8901
- 11-digit product format
- 636298901
- Labeler code
- 63629
- Product ID
- 63629-8901_8e4a9735-053b-4bff-8bb6-0b3f75d90aad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8901 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 102 | Legacy NDC | 20240113_1f8e0b6c-baeb-4942-b3f5-b4756b694e2d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8901-1 | 63629890101 | 500 TABLET, FILM COATED in 1 BOTTLE (63629-8901-1) | 2021-11-19 | 0000-00-00 | No | No | Current |