Prescription drug · ANDA
amlodipine and valsartan NDC 33342-280
Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-280-07 | 33342028007 | 30 TABLET in 1 BOTTLE (33342-280-07)Marketed from Oct 16, 2024 | |
| 33342-280-10 | 33342028010 | 90 TABLET in 1 BOTTLE (33342-280-10)Marketed from Oct 16, 2024 | |
| 33342-280-12 | 33342028012 | 10 BLISTER PACK in 1 CARTON (33342-280-12) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 16, 2024 |
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 besylate — 10 mg/1Valsartan — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207292
- 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 33342-280_d520c66f-440c-4f7e-b057-0d548c3142e7SPL ID d520c66f-440c-4f7e-b057-0d548c3142e7SPL set ID 5dfadaf0-c333-4b79-9a97-e42f77505c40RxCUI 722126, 722131, 722134, 722137UNII 864V2Q084H, 80M03YXJ7IUPC 0333342280107, 0333342282101, 0333342279071, 0333342281104, 0333342281074, 0333342282071, 0333342279101
- 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
N433342028007followed by a unit qualifier and the quantityPackage 33342-0280-07. 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 tablets, USP are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets, USP are 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 tablets, USP are indicated for the treatment of hyperte…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207292
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 besylate 5 mg/1; Valsartan 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-279 |
| amlodipine and valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-281 |
| amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-282 |