LABETALOL HYDROCHLORIDE
- Product NDC
- 71335-2169
- 11-digit product format
- 713352169
- Labeler code
- 71335
- Product ID
- 71335-2169_61f6ec35-0ee2-455a-a117-ef7a9d506342
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211953
- Marketing category
- ANDA
- Marketing start
- 2021-08-18
- 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 | 896762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2169-1 | LABETALOL HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 102 |
| 71335-2169-2 | LABETALOL HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 102 |
| 71335-2169-3 | LABETALOL HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2169 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 3 package rows | 20231128_04f9dcdf-4023-48ee-9e7d-ca9366d9db72.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 |
|---|
| 71335-2169-1 | 71335216901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2169-1) | 2022-09-06 | 0000-00-00 | No | No | Current |
| 71335-2169-2 | 71335216902 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2169-2) | 2022-09-06 | 0000-00-00 | No | No | Current |
| 71335-2169-3 | 71335216903 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2169-3) | 2022-09-06 | 0000-00-00 | No | No | Current |