Labetalol Hydrochloride
- Product NDC
- 58657-907
- 11-digit product format
- 586570907
- Labeler code
- 58657
- Product ID
- 58657-907_46b55541-52d5-7213-e063-6294a90affc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA075215
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- LABETALOL
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R5H8897N95 |
| Rxcui | 896758, 896762, 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58657-907-01 | Labetalol Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 11 |
| 58657-907-10 | Labetalol Hydrochloride | 100 in 1 BLISTER PACK | TABLET, FILM COATED | 100 | | 11 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58657-907-01 | 58657090701 | 100 BLISTER PACK in 1 CARTON (58657-907-01) / 100 TABLET, FILM COATED in 1 BLISTER PACK (58657-907-10) | 100 blister pack | 2025-07-01 | No | No | Current |
| 58657-907-10 | 58657090710 | 100 in 1 BLISTER PACK | | | | | Historical |