Labetalol Hydrochloride
- Product NDC
- 0409-2267
- 11-digit product format
- 004092267
- Labeler code
- 0409
- Product ID
- 0409-2267_c1772ea4-65eb-4f27-8e33-3de06278acfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA075240
- Marketing category
- ANDA
- Marketing start
- 2005-12-30
- 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 |
|---|
| 0409-2267-20 | Labetalol Hydrochloride | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 28 |
| 0409-2267-20 | Labetalol Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 28 |
| 0409-2267-54 | Labetalol Hydrochloride | 40 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 40 | | 28 |
| 0409-2267-54 | Labetalol Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 28 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LABETALOL HYDROCHLORIDE | ACTIVE INGREDIENT | 1GEV3BAW9J | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| LABETALOL | ACTIVE MOIETY | R5H8897N95 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-2267 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 25 | Current NDC, Legacy NDC, 4 package rows | 20241210_abfc6b75-1ed5-41f1-0484-4597488237bc.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 |
|---|
| 0409-2267-20 | 00409226720 | 1 VIAL, MULTI-DOSE in 1 CARTON (0409-2267-20) > 20 mL in 1 VIAL, MULTI-DOSE | 2006-02-01 | 0000-00-00 | No | No | Current |
| 0409-2267-54 | 00409226754 | 1 VIAL, MULTI-DOSE in 1 CARTON (0409-2267-54) / 40 mL in 1 VIAL, MULTI-DOSE | 2005-12-30 | 0000-00-00 | No | No | Current |