Prescription drug · ANDA
Labetalol Hydrochloride NDC 71247-126
Labetalol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Innogenix, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71247-126-01 | 71247012601 | 100 TABLET, FILM COATED in 1 BOTTLE (71247-126-01)Marketed from Feb 8, 2021 | |
| 71247-126-05 | 71247012605 | 500 TABLET, FILM COATED in 1 BOTTLE (71247-126-05)Marketed from Feb 8, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Innogenix, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075215
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71247-126_09304c97-8d53-4561-b157-765544fd362cSPL ID 09304c97-8d53-4561-b157-765544fd362cSPL set ID 82fc2d64-0572-4a9b-94fc-f6eb8d930c54RxCUI 896758, 896762, 896766UNII 1GEV3BAW9JUPC 0371247126014, 0371247127011, 0371247130011
- 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
N471247012601followed by a unit qualifier and the quantityPackage 71247-0126-01. 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)
Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075215
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 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1675 |
| Labetalol Hydrochloride | Labetalol 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1676 |
| Labetalol Hydrochloride | Labetalol 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1677 |
| Labetalol Hydrochloride | Labetalol 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3065 |
| Labetalol Hydrochloride | Labetalol 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2057 |
| Labetalol Hydrochloridelabetalol | Labetalol 100 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-711 |
| Labetalol Hydrochloridelabetalol | Labetalol 200 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-712 |
| Labetalol Hydrochloridelabetalol | Labetalol 300 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals Inc | 10135-713 |
| Labetalol Hydrochloride | Labetalol 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2876 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Innogenix, Inc. | 71247-127 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Innogenix, Inc. | 71247-130 |
| Labetalol Hydrochloride | Labetalol 300 mg/1 | Tablet, Film coatedOral | Method Pharmaceuticals, LLC | 58657-604 |
| Labetalol Hydrochloride | Labetalol 100 mg/1 | Tablet, Film coatedOral | Method Pharmaceuticals, LLC | 58657-602 |
| Labetalol Hydrochloride | Labetalol 200 mg/1 | Tablet, Film coatedOral | Method Pharmaceuticals, LLC | 58657-603 |
| Labetalol Hydrochloride | Labetalol 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1163 |
| Labetalol Hydrochloride | Labetalol 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1161 |
| Labetalol Hydrochloride | Labetalol 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1162 |
| Labetalol Hydrochloride | Labetalol 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1164 |
| Labetalol Hydrochloride | Labetalol 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1165 |
| Labetalol Hydrochloride | Labetalol 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1166 |
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