Labetalol Hydrochloride
- Product NDC
- 58657-606
- 11-digit product format
- 586570606
- Labeler code
- 58657
- Product ID
- 58657-606_39af022e-4753-49a9-85d4-3b6887f4bb20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA075215
- Marketing category
- ANDA
- Marketing start
- 2017-11-15
- Marketing end
- 0000-00-00
- Substance
- LABETALOL
- Active strength
- 200 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58657-606-01 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-6e1d-f424-e053-dadaa90a57ce | 57d404d2-8183-4995-91f4-b3dfeab1934d |
| 58657-606-50 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-6e1d-f424-e053-dadaa90a57ce | 57d404d2-8183-4995-91f4-b3dfeab1934d |
| 58657-606-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6e1d-f424-e053-dadaa90a57ce | 57d404d2-8183-4995-91f4-b3dfeab1934d |
| 58657-606-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6e1d-f424-e053-dadaa90a57ce | 57d404d2-8183-4995-91f4-b3dfeab1934d |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-606-01 | EA - Each | 58657-606 | 55d9eb54-70d1-4651-9937-259804faed18 | 1 | 2017-12-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 896758 | labetalol HCl 100 MG Oral Tablet | PSN | b4c13317-88eb-48f2-aba2-50f01c8ff938 | 1 |
| 896762 | labetalol HCl 200 MG Oral Tablet | PSN | b4c13317-88eb-48f2-aba2-50f01c8ff938 | 1 |
| 896766 | labetalol HCl 300 MG Oral Tablet | PSN | b4c13317-88eb-48f2-aba2-50f01c8ff938 | 1 |
| 896758 | labetalol hydrochloride 100 MG Oral Tablet | SCD | b4c13317-88eb-48f2-aba2-50f01c8ff938 | 1 |
| 896762 | labetalol hydrochloride 200 MG Oral Tablet | SCD | b4c13317-88eb-48f2-aba2-50f01c8ff938 | 1 |
| 896766 | labetalol hydrochloride 300 MG Oral Tablet | SCD | b4c13317-88eb-48f2-aba2-50f01c8ff938 | 1 |