labetalol hydrochloride
- Product NDC
- 25021-317
- 11-digit product format
- 250210317
- Labeler code
- 25021
- Product ID
- 25021-317_02cc0ab9-5ab4-4016-9ec2-b96c4cb2be41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- labetalol hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA214533
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- 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 |
|---|
| 25021-317-20 | labetalol hydrochloride | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 4 |
| 25021-317-20 | labetalol hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 25021-317-40 | labetalol hydrochloride | 40 mL in 1 VIAL | INJECTION, SOLUTION | 40 | | 4 |
| 25021-317-40 | 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 |
|---|
| 25021-317 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 4 package rows | 20221116_da8af6c2-d822-4ae5-9c2d-a1d161bdefd0.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 |
|---|
| 25021-317-20 | 25021031720 | 1 VIAL in 1 CARTON (25021-317-20) / 20 mL in 1 VIAL | 1 vial | 2022-09-01 | 0000-00-00 | No | No | Current |
| 25021-317-40 | 25021031740 | 1 VIAL in 1 CARTON (25021-317-40) / 40 mL in 1 VIAL | 1 vial | 2022-09-01 | 0000-00-00 | No | No | Current |