What is NDC 0078-0563?

0078-0563 is the product NDC for Exforge HCT, Amlodipine besylate 10 mg/1 + 2 more ingredients 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 is the active ingredient?

Amlodipine besylate, Valsartan, Hydrochlorothiazide.

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 HCT?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Exforge HCT NDC 0078-0563 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0563Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0563Add 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
0078-0563-15	0007805631500078056315	30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)Marketed from Apr 4, 2009

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 HCT
Generic name (nonproprietary): amlodipine valsartan and hydrochlorothiazide
Active ingredients: Amlodipine besylate — 10 mg/1Valsartan — 320 mg/1Hydrochlorothiazide — 25 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 022314
Marketing start: Apr 4, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 0078-0563_e10fea42-c6e7-4584-9a0a-0709c5323cd8SPL ID e10fea42-c6e7-4584-9a0a-0709c5323cd8SPL set ID 18d7820d-471f-4ee2-9ec6-25d8d27c77deRxCUI 848131, 848134, 848135, 848139, 848140, 848144, 848145, 848149, 848151, 848155UNII 80M03YXJ7I, 0J48LPH2TH, 864V2Q084H
Pharmacologic class: Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; Thiazide Diuretic

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

N400078056315 followed by a unit qualifier and the quantity

Package 00078-0563-15. 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 Dec 12, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, hydrochlorothiazide, and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, inc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-0563

What is NDC 0078-0563?: 0078-0563 is the product NDC for Exforge HCT, Amlodipine besylate 10 mg/1 + 2 more ingredients 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 HCT (Amlodipine valsartan and hydrochlorothiazide).
What is the active ingredient?: Amlodipine besylate, Valsartan, Hydrochlorothiazide.
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 HCT?: 4 other product NDCs are listed under this name. See all Exforge HCT NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Exforge HCT NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0559	00078-0559-15
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0560	00078-0560-15
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0561	00078-0561-15
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0562	00078-0562-15

Other NDCs under NDA 022314

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

FDA NDC Directory listings under NDA 022314
Product	Strength	Form · route	Labeler	Product NDC
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0559
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0560
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0561
Exforge HCTamlodipine valsartan and hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0562