Labetalol Hydrochloride
- Product NDC
- 36000-324
- 11-digit product format
- 360000324
- Labeler code
- 36000
- Product ID
- 36000-324_219d4dec-02d1-4d4b-88fd-01b1dbad3abc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA076051
- Marketing category
- ANDA
- Marketing start
- 2021-01-26
- 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, 2477889 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36000-324-01 | Labetalol Hydrochloride | 40 mL in 1 VIAL | INJECTION, SOLUTION | 40 | | 6 |
| 36000-324-02 | Labetalol Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36000-324 | LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240921_b17a7b3a-e7a5-4987-ae85-ad970e7540c7.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 |
|---|
| 36000-324-01 | 36000032401 | 40 mL in 1 VIAL | 40 ml | | | | | Historical |
| 36000-324-02 | 36000032402 | 1 VIAL in 1 CARTON (36000-324-02) / 40 mL in 1 VIAL (36000-324-01) | 1 vial | 2021-01-26 | 0000-00-00 | No | No | Current |