Labetalol Hydrochloride
- Product NDC
- 68083-111
- 11-digit product format
- 680830111
- Labeler code
- 68083
- Product ID
- 68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA090699
- Marketing category
- ANDA
- Marketing start
- 2012-04-19
- 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 |
|---|
| 68083-111-01 | Labetalol Hydrochloride | 20 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 20 | | 6 |
| 68083-111-01 | Labetalol Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 6 |
| 68083-111-02 | Labetalol Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 6 |
| 68083-111-02 | Labetalol Hydrochloride | 40 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 40 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Labetalol hydrochloride | ACTIVE INGREDIENT | 1GEV3BAW9J | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
| Labetalol | ACTIVE MOIETY | R5H8897N95 | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
| Anhydrous Dextrose | INACTIVE INGREDIENT | 5SL0G7R0OK | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE ) INJECTION, SOLUTION [GLAND PHARMA LIMITED ] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-111 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240522_48caf986-3126-48e1-afcd-16d65c9cfe00.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 |
|---|
| 68083-111-01 | 68083011101 | 10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASS | 2012-04-19 | 0000-00-00 | No | No | Current |
| 68083-111-02 | 68083011102 | 10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASS | 2012-04-19 | 0000-00-00 | No | No | Current |