Labetalol Hydrochloride
- Product NDC
- 50090-6833
- 11-digit product format
- 500906833
- Labeler code
- 50090
- Product ID
- 50090-6833_7615303f-6f49-4281-bf0d-5c49bbaa7ae2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA075215
- Marketing category
- ANDA
- Marketing start
- 2021-02-08
- 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
- 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 HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896766 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6833-1 | 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 |
|---|
| 50090-6833 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, 1 package rows | 20250516_5faacbcc-f88f-42f7-8702-791ee82c4d18.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6833-1 | 50090683301 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6833-1) | 2023-11-21 | No | No | Historical |