Labetalol Hydrochloride
- Product NDC
- 72603-903
- 11-digit product format
- 726030903
- Labeler code
- 72603
- Product ID
- 72603-903_2a23ecd8-4a58-4f02-8bcd-e112364b12e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA074787
- Marketing category
- ANDA
- Marketing start
- 2026-03-19
- Substance
- LABETALOL HYDROCHLORIDE
- 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 HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758, 896762, 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-903-01 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 72603-903-02 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-903-01 | 72603090301 | 100 TABLET in 1 BOTTLE (72603-903-01) | 100 tablet | 2026-03-19 | No | No | Current |
| 72603-903-02 | 72603090302 | 500 TABLET in 1 BOTTLE (72603-903-02) | 500 tablet | 2026-03-19 | No | No | Current |