Labetalol Hydrochloride
- Product NDC
- 72266-102
- 11-digit product format
- 722660102
- Labeler code
- 72266
- Product ID
- 72266-102_189abc58-65af-e772-e063-6394a90a5ed3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fosun Pharma USA Inc.
- Application
- ANDA090699
- Marketing category
- ANDA
- Marketing start
- 2019-04-02
- 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 |
|---|
| 72266-102-01 | Labetalol Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 72266-102-01 | Labetalol Hydrochloride | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72266-102 | LABETALOL HYDROCHLORIDE INJECTION [FOSUN PHARMA USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240518_4a5ffab2-a3b8-411e-992d-7f38d508643a.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 |
|---|
| 72266-102-01 | 72266010201 | 1 VIAL, MULTI-DOSE in 1 CARTON (72266-102-01) / 20 mL in 1 VIAL, MULTI-DOSE | 2019-04-02 | 0000-00-00 | No | No | Current |