LABETALOL HYDROCHLORIDE
- Product NDC
- 72888-468
- 11-digit product format
- 728880468
- Labeler code
- 72888
- Product ID
- 72888-468_4e7597b8-afba-8b90-e063-6394a90a85e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd
- Application
- ANDA211953
- Marketing category
- ANDA
- Marketing start
- 2025-05-20
- 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
- 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 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 |
|---|
| 72888-468-01 | LABETALOL HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 72888-468-02 | LABETALOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-468 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LTD] | 1 | Current NDC, 2 package rows | 20250523_106a0959-5830-489f-ba60-afd4eb0fac36.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72888-468-01 | 72888046801 | 500 TABLET, FILM COATED in 1 BOTTLE (72888-468-01) | 2025-05-20 | No | No | Current |
| 72888-468-02 | 72888046802 | 100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02) | 2025-05-20 | No | No | Current |