Labetalol Hydrochloride
- Product NDC
- 71930-035
- 11-digit product format
- 719300035
- Labeler code
- 71930
- Product ID
- 71930-035_5fdcf3db-a10a-4e6b-a476-31d04cee1464
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Eywa Pharma Inc
- Application
- ANDA207863
- Marketing category
- ANDA
- Marketing start
- 2019-05-24
- Marketing end
- 0000-00-00
- 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
- 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 |
|---|
| 71930-035 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [EYWA PHARMA INC] | 5 | Legacy NDC | 20250523_891c42c0-6071-5d85-e053-2995a90a4294.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71930-035-12 | 71930003512 | 100 TABLET, FILM COATED in 1 BOTTLE (71930-035-12) | 2019-05-24 | 0000-00-00 | No | No | Current |
| 71930-035-52 | 71930003552 | 500 TABLET, FILM COATED in 1 BOTTLE (71930-035-52) | 2019-05-24 | 0000-00-00 | No | No | Current |