Prescription drug · ANDA
Amlodipine and Atorvastatin NDC 62332-760
Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-760-30 | 62332076030 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-760-30)Marketed from May 23, 2025 | |
| 62332-760-90 | 62332076090 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-760-90)Marketed from May 23, 2025 |
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)
- Amlodipine and Atorvastatin
- Generic name (nonproprietary)
- amlodipine and atorvastatin
- Active ingredients
- Amlodipine besylate — 5 mg/1Atorvastatin calcium trihydrate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217279
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-760_d7b14922-f4b8-4e3e-afdd-056aee8dc35bSPL ID d7b14922-f4b8-4e3e-afdd-056aee8dc35bSPL set ID 1346631f-e6db-4c5c-a6af-5aa7b80a011dRxCUI 404011, 404013, 597967, 597971, 597974, 597977, 597980, 597984, 597987, 597990, 597993UNII 864V2Q084H, 48A5M73Z4QUPC 0362332765300, 0362332758302, 0362332764303, 0362332759309, 0362332762309, 0362332761302, 0362332763306, 0362332760305, 0362332757305, 0362332755301, 0362332756308
- Pharmacologic class
- Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; HMG-CoA Reductase Inhibitor
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
N462332076030followed by a unit qualifier and the quantityPackage 62332-0760-30. 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)
Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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 amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217279
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 |
|---|---|---|---|---|
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-755 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-758 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-756 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-757 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-762 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-759 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-761 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-763 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-764 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-765 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-758 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-755 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-756 |
| Amlodipine and Atorvastatin | Amlodipine besylate 2.5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-757 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-761 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-759 |
| Amlodipine and Atorvastatin | Amlodipine besylate 5 mg/1; Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-760 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-765 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-762 |
| Amlodipine and Atorvastatin | Amlodipine besylate 10 mg/1; Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-763 |
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