Exforge NDC 0078-0491

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0491Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0491Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0078-0491-15	00078049115	30 TABLET, FILM COATED in 1 BOTTLE (0078-0491-15)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 — 10 mg/1Valsartan — 320 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Novartis Pharmaceuticals Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021990
Marketing start: Jun 20, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 0078-0491_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 864V2Q084H, 80M03YXJ7I
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

N400078049115 followed by a unit qualifier and the quantity

Package 00078-0491-15. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 021990

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021990
Product	Strength	Form · route	Labeler	Product NDC
Exforgeamlodipine besylate and valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0488
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