Labetalol Hydrochloride
- Product NDC
- 71335-2434
- 11-digit product format
- 713352434
- Labeler code
- 71335
- Product ID
- 71335-2434_41d78266-20c3-e397-e063-6294a90a1c20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- 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 | 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2434-1 | Labetalol Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 71335-2434-2 | Labetalol Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 71335-2434-3 | Labetalol Hydrochloride | 58 in 1 BOTTLE | TABLET, FILM COATED | 58 | | 2 |
| 71335-2434-4 | Labetalol Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 71335-2434-5 | Labetalol Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2434 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1 | Current NDC, 5 package rows | 20240719_dafa7411-2857-4f5a-a587-4367cfbe2bfa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2434-1 | 71335243401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2434-1) | 2024-07-15 | No | No | Historical |
| 71335-2434-2 | 71335243402 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2434-2) | 2024-07-15 | No | No | Historical |
| 71335-2434-3 | 71335243403 | 58 TABLET, FILM COATED in 1 BOTTLE (71335-2434-3) | 2024-07-15 | No | No | Historical |
| 71335-2434-4 | 71335243404 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2434-4) | 2024-07-15 | No | No | Historical |
| 71335-2434-5 | 71335243405 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2434-5) | 2024-07-15 | No | No | Historical |