Prescription drug · ANDA
Amlodipine and Valsartan NDC 51407-771
Amlodipine 5 mg/1; Valsartan 160 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-771-30 | 51407077130 | 30 TABLET in 1 BOTTLE, PLASTIC (51407-771-30)Marketed from May 6, 2023 |
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 Valsartan
- Generic name (nonproprietary)
- amlodipine and valsartan
- Active ingredients
- Amlodipine — 5 mg/1Valsartan — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090011
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 51407-771_4f9c77d6-c13d-7ccb-e063-6394a90ae49fSPL ID 4f9c77d6-c13d-7ccb-e063-6394a90ae49fSPL set ID fed14445-1117-861a-e053-6294a90a2aa3RxCUI 722126, 722131, 722134, 722137UNII 80M03YXJ7I, 1J444QC288
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel 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
N451407077130followed by a unit qualifier and the quantityPackage 51407-0771-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Amlodipine and valsartan is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on monotherapy ( 1 ) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090011
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 Valsartan | Amlodipine 5 mg/1; Valsartan 320 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-846 |
| Amlodipine and Valsartan | Amlodipine 5 mg/1; Valsartan 320 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-772 |
| Amlodipine and Valsartan | Amlodipine 5 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-844 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-845 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 320 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-847 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 160 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-773 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 320 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-774 |