Labetalol Hydrochloride
- Product NDC
- 29300-253
- 11-digit product format
- 293000253
- Labeler code
- 29300
- Product ID
- 29300-253_8325a41d-d05c-4c6b-b2fc-260c9380bfba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA212719
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- 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
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758, 896762, 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-253-01 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 29300-253-05 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-253 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221001_ed0188ba-3fd3-4680-a829-ba242a115fab.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 |
|---|
| 29300-253-01 | 29300025301 | 100 TABLET, FILM COATED in 1 BOTTLE (29300-253-01) | 2022-10-01 | 0000-00-00 | No | No | Current |
| 29300-253-05 | 29300025305 | 500 TABLET, FILM COATED in 1 BOTTLE (29300-253-05) | 2022-10-01 | 0000-00-00 | No | No | Current |