Labetalol Hydrochloride
- Product NDC
- 58657-603
- 11-digit product format
- 586570603
- Labeler code
- 58657
- Product ID
- 58657-603_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
- 2019-11-22
- 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 |
|---|
| 58657-603-01 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 58657-603-10 | Labetalol Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
| 58657-603-50 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58657-603 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [METHOD PHARMACEUTICALS, LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20241126_733d6e32-ac90-4796-bf25-9d5887c897a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58657-603-01 | 58657060301 | 100 TABLET, FILM COATED in 1 BOTTLE (58657-603-01) | 2019-11-22 | 0000-00-00 | No | No | Current |
| 58657-603-10 | 58657060310 | 1000 TABLET, FILM COATED in 1 BOTTLE (58657-603-10) | 2019-11-22 | 0000-00-00 | No | No | Current |
| 58657-603-50 | 58657060350 | 500 TABLET, FILM COATED in 1 BOTTLE (58657-603-50) | 2019-11-22 | 0000-00-00 | No | No | Current |