NDC codes

FDA NDC Directory
Product NDC (as listed)71205-258Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0258Add 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 NDC11-digit (billing)PackageCopy
71205-258-30712050258307120502583030 TABLET, FILM COATED in 1 BOTTLE (71205-258-30)Marketed from May 1, 2019
71205-258-60712050258607120502586060 TABLET, FILM COATED in 1 BOTTLE (71205-258-60)Marketed from May 1, 2019
71205-258-90712050258907120502589090 TABLET, FILM COATED in 1 BOTTLE (71205-258-90)Marketed from May 1, 2019

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)
Valsartan and Hydrochlorothiazide
Generic name (nonproprietary)
valsartan and hydrochlorothiazide
Active ingredients
Valsartan — 160 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203145
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 71205-258_09764c50-8d91-4c74-8d5f-d48f79ecb01cSPL ID 09764c50-8d91-4c74-8d5f-d48f79ecb01cSPL set ID a9098fc6-3d2a-404f-a4cd-2e181ebbd626RxCUI 200285UNII 80M03YXJ7I, 0J48LPH2THUPC 0371205258306
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.

NDC on a medical claim

N471205025830 followed by a unit qualifier and the quantity

Package 71205-0258-30. 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)

Valsartan and hydrochlorothiazide tablets, USP are 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 hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, l…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-258

What is NDC 71205-258?
71205-258 is the product NDC for Valsartan and Hydrochlorothiazide, Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Valsartan and Hydrochlorothiazide.
What is the active ingredient?
Valsartan, Hydrochlorothiazide.
Who is the labeler?
Proficient Rx LP, NDC labeler code 71205. 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?
98 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 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14850228-0148-1050228-0148-30
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-14750228-0147-1050228-0147-30
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals, INC.50228-15150228-0151-0550228-0151-30
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 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07384677-0073-90
Valsartan And HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07284677-0072-90
Valsartan And HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-07684677-0076-90
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

All 99 Valsartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 203145

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

FDA NDC Directory listings under ANDA 203145
ProductStrengthForm · routeLabelerProduct NDC
Valsartan and HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-074
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-075
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1TabletOralMacleods Pharmaceuticals Limited33342-076
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-077
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-078
Valsartan and HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3576
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5345
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5570
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1TabletOralA-S Medication Solutions50090-6210
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-655
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-698
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-7282
Valsartan and HydrochlorothiazideValsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralProficient Rx LP71205-327
Valsartan and HydrochlorothiazideValsartan 320 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0547
Valsartan and HydrochlorothiazideValsartan 160 mg/1; Hydrochlorothiazide 25 mg/1TabletOralNorthwind Health Company, LLC82868-054

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