NDC codes

FDA NDC Directory
Product NDC (as listed)68180-102Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0102Add the package segment from the table below.

Product information

Brand name (proprietary)
Valsartan and Hydrochlorothiazide
Generic name (nonproprietary)
valsartan and hydrochlorothiazide
Active ingredients
Hydrochlorothiazide — 25 mg/1Valsartan — 320 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078946
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 68180-102_537df828-cd82-4b5e-9d0d-da8bd1cfd736SPL ID 537df828-cd82-4b5e-9d0d-da8bd1cfd736SPL set ID d74a85de-5917-401a-b92d-6a95da5d30a6RxCUI 200284, 200285, 349353, 636042, 636045UNII 0J48LPH2TH, 80M03YXJ7IUPC 0368180105091, 0368180103097, 0368180104094
Pharmacologic class
Angiotensin 2 Receptor 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.

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Valsartan and hydrochlorothiazide tablet USP is the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled with 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. Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-102

What is NDC 68180-102?
68180-102 is the product NDC for Valsartan and Hydrochlorothiazide, Hydrochlorothiazide 25 mg/1; Valsartan 320 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc..
What drug is associated with this NDC?
Valsartan and Hydrochlorothiazide.
What is the active ingredient?
Hydrochlorothiazide, Valsartan.
Who is the labeler?
Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valsartan and Hydrochlorothiazide?
97 other product NDCs are listed under this name. See all Valsartan and Hydrochlorothiazide 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 Valsartan and Hydrochlorothiazide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14750228-0147-1050228-0147-30
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14850228-0148-1050228-0148-30
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14950228-0149-1050228-0149-30
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-15050228-0150-0550228-0150-30
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-15150228-0151-0550228-0151-30
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07284677-0072-90
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07384677-0073-90
Valsartan And HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07484677-0074-90
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07584677-0075-90
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07684677-0076-90

All 98 Valsartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 078946

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

FDA NDC Directory listings under ANDA 078946
ProductStrengthForm · routeLabelerProduct NDC
Valsartan and HydrochlorothiazideHydrochlorothiazide 12.5 mg/1; Valsartan 320 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-101
Valsartan and HydrochlorothiazideHydrochlorothiazide 12.5 mg/1; Valsartan 80 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-103
Valsartan and HydrochlorothiazideHydrochlorothiazide 12.5 mg/1; Valsartan 160 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-104
Valsartan and HydrochlorothiazideHydrochlorothiazide 25 mg/1; Valsartan 160 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-105
Valsartan and HydrochlorothiazideHydrochlorothiazide 12.5 mg/1; Valsartan 80 mg/1Tablet, Film coatedOralProficient Rx LP71205-249

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