Labetalol Hydrochloride
- Product NDC
- 23155-723
- 11-digit product format
- 231550723
- Labeler code
- 23155
- Product ID
- 23155-723_50a37968-605e-481b-af03-db963542a6c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA074787
- Marketing category
- ANDA
- Marketing start
- 2020-02-22
- 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, 896762, 896766, 896983 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23155-723-01 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 23155-723-05 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-723 | LABETALOL HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220415_bf84ebae-3c91-4448-b1db-8e5ed3053866.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 23155-723-01 | 23155072301 | 100 TABLET in 1 BOTTLE (23155-723-01) | 100 tablet | 2020-02-22 | 0000-00-00 | No | No | Current |
| 23155-723-05 | 23155072305 | 500 TABLET in 1 BOTTLE (23155-723-05) | 500 tablet | 2020-02-22 | 0000-00-00 | No | No | Current |