Labetalol Hydrochloride
- Product NDC
- 83301-0059
- 11-digit product format
- 833010059
- Labeler code
- 83301
- Product ID
- 83301-0059_e49bc25a-e39e-469a-8372-bd28e2b1ca7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Mullan Pharmaceutical Inc.
- Application
- ANDA090699
- Marketing category
- ANDA
- Marketing start
- 2025-12-05
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 200 mg/40mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Labetalol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LABETALOL HYDROCHLORIDE | 200 mg/40mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896771 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83301-0059-1 | Labetalol Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 83301-0059-1 | Labetalol Hydrochloride | 40 mL in 1 VIAL, MULTI-DOSE | INJECTION | 40 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83301-0059-1 | 83301005901 | 1 VIAL, MULTI-DOSE in 1 CARTON (83301-0059-1) / 40 mL in 1 VIAL, MULTI-DOSE | 2025-12-05 | No | No | Current |