LABETALOL HYDROCHLORIDE
- Product NDC
- 70518-3499
- 11-digit product format
- 705183499
- Labeler code
- 70518
- Product ID
- 70518-3499_4f1df0e1-e950-902d-e063-6394a90a6ff4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211953
- Marketing category
- ANDA
- Marketing start
- 2022-08-25
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LABETALOL HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LABETALOL HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3499-0 | LABETALOL HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 5 |
| 70518-3499-1 | LABETALOL HYDROCHLORIDE | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 5 |
| 70518-3499-2 | LABETALOL HYDROCHLORIDE | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3499 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240116_ae5d7b3b-e444-48d3-9d85-9b07319f9374.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 |
|---|
| 70518-3499-0 | 70518349900 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3499-0) | 2022-08-25 | 0000-00-00 | No | No | Current |
| 70518-3499-1 | 70518349901 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3499-1) | 2022-09-20 | 0000-00-00 | No | No | Current |
| 70518-3499-2 | 70518349902 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3499-2) | 2022-09-20 | 0000-00-00 | No | No | Current |