Labetalol Hydrochloride
- Product NDC
- 63629-1162
- 11-digit product format
- 636291162
- Labeler code
- 63629
- Product ID
- 63629-1162_6fde10dc-e1bd-4a98-b5aa-00e6888e4b2a
- 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
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R5H8897N95 |
| Rxcui | 896758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-1162-1 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-1162 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC, 1 package rows | 20241013_143ae21e-c350-4c92-b318-7537f4e46596.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 |
|---|
| 63629-1162-1 | 63629116201 | 500 TABLET, FILM COATED in 1 BOTTLE (63629-1162-1) | 2019-11-22 | 0000-00-00 | No | No | Current |