Labetalol Hydrochloride
- Product NDC
- 70518-3993
- 11-digit product format
- 705183993
- Labeler code
- 70518
- Product ID
- 70518-3993_3f8fc907-586d-8e31-e063-6294a90a40a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2024-01-24
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 200 mg/1
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3993-0 | Labetalol Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 5 |
| 70518-3993-1 | Labetalol Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 5 |
| 70518-3993-2 | Labetalol Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3993 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 4 | Current NDC, 3 package rows | 20250122_5101b8dd-6148-465c-9bba-0209ce823fe5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3993-0 | 70518399300 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-0) | 2024-01-24 | No | No | Historical |
| 70518-3993-1 | 70518399301 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-1) | 2024-01-24 | No | No | Historical |
| 70518-3993-2 | 70518399302 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3993-2) | 2025-01-20 | No | No | Historical |