Labetalol Hydrochloride
- Product NDC
- 67296-2114
- 11-digit product format
- 672962114
- Labeler code
- 67296
- Product ID
- 67296-2114_3b0aa187-8058-8e3b-e063-6294a90a373e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RedPharm Drug
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-2114-2 | Labetalol Hydrochloride | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 2 |
| 67296-2114-6 | Labetalol Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-2114 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG] | 1 | Current NDC, 2 package rows | 20240727_1e1b7355-4802-d277-e063-6394a90aef44.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-2114-2 | 67296211402 | 21 TABLET, FILM COATED in 1 BOTTLE (67296-2114-2) | 2021-05-27 | No | No | Current |
| 67296-2114-6 | 67296211406 | 60 TABLET, FILM COATED in 1 BOTTLE (67296-2114-6) | 2021-05-27 | No | No | Current |