Labetalol Hydrochloride
- Product NDC
- 70518-4201
- 11-digit product format
- 705184201
- Labeler code
- 70518
- Product ID
- 70518-4201_3ff4f9b1-7aa2-e196-e063-6294a90ae2e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075215
- Marketing category
- ANDA
- Marketing start
- 2024-10-02
- Substance
- LABETALOL
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R5H8897N95 |
| Rxcui | 896758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4201-0 | Labetalol Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4201 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, 1 package rows | 20241213_e2e50571-d8c1-43e7-b90f-877ba1c35c9b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4201-0 | 70518420100 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4201-0) | 2024-10-02 | No | No | Current |