LABETALOL HYDROCHLORIDE
- Product NDC
- 70518-3557
- 11-digit product format
- 705183557
- Labeler code
- 70518
- Product ID
- 70518-3557_f0d49ffc-0bff-4ddd-e053-2a95a90ac59c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211953
- Marketing category
- ANDA
- Marketing start
- 2022-10-17
- 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 |
|---|
| 70518-3557 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 2 | Legacy NDC | 20240116_9c8b6c4d-04e8-41e0-819e-162790b25590.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3557-0 | 70518355700 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3557-0) | 2022-10-17 | 0000-00-00 | No | No | Current |