Prescription drug · ANDA
Labetalol Hydrochloride NDC 50090-6741
Labetalol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6741-0 | 50090674100 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6741-0)Marketed from Oct 13, 2023 | |
| 50090-6741-1 | 50090674101 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6741-1)Marketed from Oct 13, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Labetalol Hydrochloride
- Generic name (nonproprietary)
- labetalol hydrochloride
- Active ingredients
- Labetalol hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211953
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 50090-6741_bee54e03-a973-47f7-b726-5d7f6d3bf61eSPL ID bee54e03-a973-47f7-b726-5d7f6d3bf61eSPL set ID c586ab65-56e8-4a4f-b471-902198d3e58cRxCUI 896758UNII 1GEV3BAW9J
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090674100followed by a unit qualifier and the quantityPackage 50090-6741-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211953
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-468 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2156 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7666 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6774 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-784 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2169 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7731 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3499 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-120 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-121 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-122 |