Labetalol Hydrochloride
- Product NDC
- 17478-420
- 11-digit product format
- 174780420
- Labeler code
- 17478
- Product ID
- 17478-420_e3f803c8-a2c8-4ec8-a9be-fb9f730aafdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Akorn
- Application
- ANDA075431
- Marketing category
- ANDA
- Marketing start
- 2004-09-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17478-420-20 | Labetalol Hydrochloride | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 9 |
| 17478-420-20 | Labetalol Hydrochloride | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 9 |
| 17478-420-40 | Labetalol Hydrochloride | 40 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 40 | | 9 |
| 17478-420-40 | Labetalol Hydrochloride | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Labetalol Hydrochloride | ACTIVE INGREDIENT | 1GEV3BAW9J | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Labetalol | ACTIVE MOIETY | R5H8897N95 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Anhydrous Citric Acid | INACTIVE INGREDIENT | XF417D3PSL | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Anhydrous Dextrose | INACTIVE INGREDIENT | 5SL0G7R0OK | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-420 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [AKORN] | 9 | Legacy NDC, 4 package rows | 20220914_17bb21ce-9bb1-4603-b168-abea7fc85d17.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 |
|---|
| 17478-420-20 | 17478042020 | 1 VIAL, MULTI-DOSE in 1 BOX (17478-420-20) > 20 mL in 1 VIAL, MULTI-DOSE | 2004-09-01 | 0000-00-00 | No | No | Current |
| 17478-420-40 | 17478042040 | 1 VIAL, MULTI-DOSE in 1 BOX (17478-420-40) > 40 mL in 1 VIAL, MULTI-DOSE | 2004-09-01 | 0000-00-00 | No | No | Current |