Labetalol HCL
- Product NDC
- 50090-1291
- 11-digit product format
- 500901291
- Labeler code
- 50090
- Product ID
- 50090-1291_e1aaf974-aad8-451d-a163-3bba37bd0b1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA200908
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-1291-0 | 2023-02-07 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
| 50090-1291-1 | 2023-02-07 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
| 50090-1291-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
| 50090-1291-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
| 50090-1291-0 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
| 50090-1291-1 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
| 50090-1291-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
| 50090-1291-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c3a6-f424-e053-dadaa90a57ce | Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-1291-0 | Labetalol HCL | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 45 |
| 50090-1291-1 | Labetalol HCL | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 45 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1291 | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 43 | Legacy NDC, 2 package rows | 20250406_312dde0d-5147-483e-968f-4e0d46114176.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 |
|---|
| 50090-1291-0 | 50090129100 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1291-0) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1291-1 | 50090129101 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1291-1) | 2015-08-06 | 0000-00-00 | No | No | Current |