Labetalol Hydrochloride
- Product NDC
- 65145-124
- 11-digit product format
- 651450124
- Labeler code
- 65145
- Product ID
- 65145-124_24f8e54c-549c-41c6-aed6-f4036dd6f11f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA214533
- Marketing category
- ANDA
- Marketing start
- 2025-02-14
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 5 mg/mL
- 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896771 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-124-01 | Labetalol Hydrochloride | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 4 |
| 65145-124-01 | Labetalol Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-124 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CAPLIN STERILES LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250216_77152699-1ca8-442a-8cb4-80b0ffbec6f2.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 |
|---|
| 65145-124-01 | 65145012401 | 1 VIAL, MULTI-DOSE in 1 CARTON (65145-124-01) / 20 mL in 1 VIAL, MULTI-DOSE | 2025-02-14 | 0000-00-00 | No | No | Current |