Labetalol Hydrochloride
- Product NDC
- 71209-083
- 11-digit product format
- 712090083
- Labeler code
- 71209
- Product ID
- 71209-083_72d9c230-fb71-4b4b-a4d2-01bf96153ec2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cadila Pharmaceuticals Limited
- Application
- ANDA211325
- Marketing category
- ANDA
- Marketing start
- 2018-05-29
- 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, 896762, 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71209-083-03 | Labetalol Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 71209-083-05 | Labetalol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 71209-083-10 | Labetalol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 71209-083-11 | Labetalol Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71209-083 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] | 5 | Current NDC, Legacy NDC, 4 package rows | 20221212_5fba93fc-4580-48c2-a1ec-5d446680adcf.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 |
|---|
| 71209-083-03 | 71209008303 | 60 TABLET, FILM COATED in 1 BOTTLE (71209-083-03) | 2018-06-30 | 0000-00-00 | No | No | Current |
| 71209-083-05 | 71209008305 | 100 TABLET, FILM COATED in 1 BOTTLE (71209-083-05) | 2022-11-24 | 0000-00-00 | No | No | Current |
| 71209-083-10 | 71209008310 | 500 TABLET, FILM COATED in 1 BOTTLE (71209-083-10) | 2022-11-24 | 0000-00-00 | No | No | Current |
| 71209-083-11 | 71209008311 | 1000 TABLET, FILM COATED in 1 BOTTLE (71209-083-11) | 2018-06-30 | 0000-00-00 | No | No | Current |