Labetalol Hydrochloride
- Product NDC
- 33342-517
- 11-digit product format
- 333420517
- Labeler code
- 33342
- Product ID
- 33342-517_366134cd-6244-45fc-99f1-0193a0221b3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA217949
- Marketing category
- ANDA
- Marketing start
- 2025-09-23
- 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
- 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758, 896762, 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-517-11 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 33342-517-15 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-517-11 | 33342051711 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-517-11) | 2025-09-23 | No | No | Historical |
| 33342-517-15 | 33342051715 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-517-15) | 2025-09-23 | No | No | Historical |