Prescription drug · NDA
Exforge (Amlodipine besylate and valsartan) NDC 0078-0488
Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0488-15 | 0007804881500078048815 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15)Marketed from Jun 20, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Exforge
- Generic name (nonproprietary)
- amlodipine besylate and valsartan
- Active ingredients
- Amlodipine besylate — 5 mg/1Valsartan — 160 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021990
- 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 0078-0488_7e675018-c404-4ea5-ac95-a18d7cb78301SPL ID 7e675018-c404-4ea5-ac95-a18d7cb78301SPL set ID d0caec89-96ec-411d-a933-63eda74a6da7RxCUI 722126, 722131, 722134, 722137, 724879, 724887, 724891, 724895UNII 80M03YXJ7I, 864V2Q084H
- 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
N400078048815followed by a unit qualifier and the quantityPackage 00078-0488-15. 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)
Exforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge 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. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8 Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8 Figure…
Excerpt only. Read the full label for complete information.
About NDC 0078-0488
- What is NDC 0078-0488?
- 0078-0488 is the product NDC for Exforge, Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Exforge (Amlodipine besylate and valsartan).
- What is the active ingredient?
- Amlodipine besylate, Valsartan.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Exforge?
- 3 other product NDCs are listed under this name. See all Exforge NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exforge products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exforgeamlodipine besylate and valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0489 | 00078-0489-15 |
| Exforgeamlodipine besylate and valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0490 | 00078-0490-15 |
| Exforgeamlodipine besylate and valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0491 | 00078-0491-15 |
Other NDCs under NDA 021990
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 |
|---|---|---|---|---|
| Exforgeamlodipine besylate and valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0489 |
| Exforgeamlodipine besylate and valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0490 |
| Exforgeamlodipine besylate and valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0491 |