Labetalol Hydrochloride
- Product NDC
- 51407-615
- 11-digit product format
- 514070615
- Labeler code
- 51407
- Product ID
- 51407-615_4f9b6911-a34d-5d03-e063-6294a90a7b82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2018-06-20
- 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 |
|---|
| 51407-615-01 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 51407-615-05 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-615 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241228_d5ce687f-4a37-d3e6-e053-2995a90aa974.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51407-615-01 | 51407061501 | 100 TABLET, FILM COATED in 1 BOTTLE (51407-615-01) | 2021-12-03 | 0000-00-00 | No | No | Current |
| 51407-615-05 | 51407061505 | 500 TABLET, FILM COATED in 1 BOTTLE (51407-615-05) | 2021-12-03 | 0000-00-00 | No | No | Current |