Labetalol Hydrochloride
- Product NDC
- 62135-800
- 11-digit product format
- 621350800
- Labeler code
- 62135
- Product ID
- 62135-800_44fde4f9-0088-6476-e063-6394a90a6a92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA074787
- Marketing category
- ANDA
- Marketing start
- 2020-02-22
- 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 | 896758, 896762, 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-800-60 | Labetalol Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-800 | LABETALOL HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241030_ac439c08-1e47-4306-8308-b31d7a1a443c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-800-60 | 62135080060 | 60 TABLET in 1 BOTTLE (62135-800-60) | 60 tablet | 2023-10-24 | No | No | Current |