Labetalol Hydrochloride
- Product NDC
- 71335-2057
- 11-digit product format
- 713352057
- Labeler code
- 71335
- Product ID
- 71335-2057_234a948f-c052-44be-9400-caea7b33eb74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Labetalol Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LABETALOL | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R5H8897N95 |
| Rxcui | 896762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2057-1 | Labetalol Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 103 |
| 71335-2057-2 | Labetalol Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 103 |
| 71335-2057-3 | Labetalol Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2057 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 3 package rows | 20240423_6f919513-500e-4a05-935e-b6fc1615368a.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 |
|---|
| 71335-2057-1 | 71335205701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2057-1) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-2057-2 | 71335205702 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2057-2) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-2057-3 | 71335205703 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2057-3) | 2022-03-03 | 0000-00-00 | No | No | Current |