Labetalol Hydrochloride
- Product NDC
- 43199-037
- 11-digit product format
- 431990037
- Labeler code
- 43199
- Product ID
- 43199-037_68106801-f71a-40be-4845-45bcfa618de6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- labetalol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- County Line Pharmaceuticals LLC
- Application
- NDA018716
- Marketing category
- NDA
- Marketing start
- 2014-12-01
- Marketing end
- 2020-11-01
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf61d8c-dcd3-e95d-db84-9bb0d0a2b77f | Product name | 2 | 20220311 |
| 759f1c41-9262-4238-8cee-33988631aaf4 | Product name | 5 | 20220217 |
| 3b2edbb4-6acf-4674-b1d9-22addd3dad21 | Product name | 1 | 20210527 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43199-037-01 | EA - Each | 43199-037 | 92f56366-8e3f-4ab3-90de-245e981d4f42 | 1 | 2014-12-01 |
| 43199-037-05 | EA - Each | 43199-037 | 10b8c97d-97ed-40ec-8c75-b600ce99c6a9 | 1 | 2015-11-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 896758 | labetalol HCl 100 MG Oral Tablet | PSN | b3752f70-9972-4327-9ca6-882da762acb3 | 2 |
| 896758 | labetalol hydrochloride 100 MG Oral Tablet | SCD | b3752f70-9972-4327-9ca6-882da762acb3 | 2 |