Labetalol Hydrochloride
- Product NDC
- 68382-800
- 11-digit product format
- 683820800
- Labeler code
- 68382
- Product ID
- 68382-800_49639538-dfdd-4312-9664-701e8bdbe191
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207743
- Marketing category
- ANDA
- Marketing start
- 2017-12-05
- 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
- 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 | 300 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 |
|---|
| 68382-800-01 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 68382-800-05 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 68382-800-06 | Labetalol Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 68382-800-16 | Labetalol Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-800 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20221014_5942a5a8-c3c1-4ecb-921e-9bc92393bdf8.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 |
|---|
| 68382-800-01 | 68382080001 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-800-01) | 2017-12-05 | 0000-00-00 | No | No | Current |
| 68382-800-05 | 68382080005 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-800-05) | 2017-12-05 | 0000-00-00 | No | No | Current |
| 68382-800-06 | 68382080006 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-800-06) | 2017-12-05 | 0000-00-00 | No | No | Current |
| 68382-800-16 | 68382080016 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-800-16) | 2017-12-05 | 0000-00-00 | No | No | Current |