Labetalol Hydrochloride
- Product NDC
- 72162-1677
- 11-digit product format
- 721621677
- Labeler code
- 72162
- Product ID
- 72162-1677_efbf3c75-cdb2-45e9-a6de-f87546c16d3c
- 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
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R5H8897N95 |
| Rxcui | 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72162-1677-1 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 107 |
| 72162-1677-5 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 107 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-1677 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 106 | Current NDC, 2 package rows | 20250112_f7f7fade-98a6-4741-bfb9-f1eb54ad4565.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-1677-1 | 72162167701 | 100 TABLET, FILM COATED in 1 BOTTLE (72162-1677-1) | 2019-11-22 | No | No | Current |
| 72162-1677-5 | 72162167705 | 500 TABLET, FILM COATED in 1 BOTTLE (72162-1677-5) | 2019-11-22 | No | No | Current |