LABETALOL HCl
- Product NDC
- 51662-1602
- 11-digit product format
- 516621602
- Labeler code
- 51662
- Product ID
- 51662-1602_ea035948-1a97-5d6e-e053-2995a90a3e7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LABETALOL HCl
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA075303
- Marketing category
- ANDA
- Marketing start
- 2022-08-29
- 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 HCl
- 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 |
|---|
| 51662-1602-1 | LABETALOL HCl | 1 in 1 BOX, UNIT-DOSE | INJECTION | 1 | | 2 |
| 51662-1602-1 | LABETALOL HCl | 20 mL in 1 VIAL | INJECTION | 20 | | 2 |
| 51662-1602-9 | LABETALOL HCl | 20 mL in 1 VIAL | INJECTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1602 | LABETALOL HCL INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Current NDC, Legacy NDC, 3 package rows | 20221002_e76c4b37-4a34-249d-e053-2995a90aa9be.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 |
|---|
| 51662-1602-1 | 51662160201 | 1 VIAL in 1 BOX, UNIT-DOSE (51662-1602-1) / 20 mL in 1 VIAL | 1 vial | 2022-08-29 | 0000-00-00 | No | No | Current |
| 51662-1602-9 | 51662160209 | 20 mL in 1 VIAL (51662-1602-9) | 20 ml | 2022-10-01 | 0000-00-00 | No | No | Current |