Labetalol Hydrochloride
- Product NDC
- 50090-7457
- 11-digit product format
- 500907457
- Labeler code
- 50090
- Product ID
- 50090-7457_b31f7695-70fc-4421-9bf3-631882d6a770
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7457-0 | Labetalol Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 50090-7457-1 | Labetalol Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7457 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20241120_d207396a-068e-4229-88cc-a1a4df7aeff2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7457-0 | 50090745700 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-7457-0) | 2024-11-14 | No | No | Historical |
| 50090-7457-1 | 50090745701 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7457-1) | 2024-11-14 | No | No | Historical |