Labetalol Hydrochloride
- Product NDC
- 0641-6252
- 11-digit product format
- 006416252
- Labeler code
- 0641
- Product ID
- 0641-6252_fa0062c6-f563-4d33-a540-fc2c7e91315d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA213330
- Marketing category
- NDA
- Marketing start
- 2022-03-18
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 5 mg/mL
- 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 |
|---|
| 0641-6252 | LABETALOL HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Legacy NDC | 20240410_1c9d496d-cace-4283-82bb-6dcd3828b73e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0641-6252-10 | 00641625210 | 10 SYRINGE, GLASS in 1 CARTON (0641-6252-10) > 2 mL in 1 SYRINGE, GLASS | 2022-03-18 | 0000-00-00 | No | No | Current |