Labetalol Hydrochloride
- Product NDC
- 42806-327
- 11-digit product format
- 428060327
- Labeler code
- 42806
- Product ID
- 42806-327_b950655d-a9f8-4ace-bb56-0c7abbca231e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA212990
- Marketing category
- ANDA
- Marketing start
- 2021-09-30
- 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
- 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 | 100 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 |
|---|
| 42806-327-01 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 42806-327-05 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 42806-327-10 | Labetalol Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-327 | LABETALOL HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20211116_b950655d-a9f8-4ace-bb56-0c7abbca231e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42806-327-01 | 42806032701 | 100 TABLET in 1 BOTTLE (42806-327-01) | 100 tablet | 2021-09-30 | 0000-00-00 | No | No | Current |
| 42806-327-05 | 42806032705 | 500 TABLET in 1 BOTTLE (42806-327-05) | 500 tablet | 2021-09-30 | 0000-00-00 | No | No | Current |
| 42806-327-10 | 42806032710 | 1000 TABLET in 1 BOTTLE (42806-327-10) | 1000 tablet | 2021-09-30 | 0000-00-00 | No | No | Current |