Labetalol Hydrochloride
- Product NDC
- 63629-8903
- 11-digit product format
- 636298903
- Labeler code
- 63629
- Product ID
- 63629-8903_bf571e99-de4f-462c-ae9f-d77c75c72217
- 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
- 300 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 |
|---|
| 63629-8903 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 102 | Legacy NDC | 20240113_87c6815a-5663-496c-a09f-02a30f1b337a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8903-1 | 63629890301 | 500 TABLET, FILM COATED in 1 BOTTLE (63629-8903-1) | 2021-11-19 | 0000-00-00 | No | No | Current |