Labetalol hydrochloride
- Product NDC
- 71205-095
- 11-digit product format
- 712050095
- Labeler code
- 71205
- Product ID
- 71205-095_5179866d-f336-4e03-85b0-972fbedb6b9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075133
- Marketing category
- ANDA
- Marketing start
- 1998-08-03
- 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
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-095-30 | Labetalol hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
| 71205-095-60 | Labetalol hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 4 |
| 71205-095-90 | Labetalol hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-095 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20221104_c0301841-e209-4242-bace-58a20e6dd01b.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 |
|---|
| 71205-095-30 | 71205009530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-30) | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-095-60 | 71205009560 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-60) | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-095-90 | 71205009590 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-90) | 2018-08-01 | 0000-00-00 | No | No | Current |