NDC codes

FDA NDC Directory
Product NDC (as listed)82868-011Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82868-0011Add 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
82868-011-308286800113030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-011-30)Marketed from Sep 5, 2023

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
Generic name (nonproprietary)
valsartan
Active ingredients
Valsartan — 160 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Northwind Health Company, LLCNDC labeler code 82868
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205536
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 82868-011_55146f84-49fa-0e7b-e063-6294a90af905SPL ID 55146f84-49fa-0e7b-e063-6294a90af905SPL set ID 04b3c573-4ef7-5cf6-e063-6294a90a2c5fRxCUI 349201UNII 80M03YXJ7I

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

N482868001130 followed by a unit qualifier and the quantity

Package 82868-0011-30. 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 tablet is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV),to reduce hospitalization for heart failure in adults ( 1.2 ) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower bl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82868-011

What is NDC 82868-011?
82868-011 is the product NDC for Valsartan, Valsartan 160 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Valsartan.
What is the active ingredient?
Valsartan.
Who is the labeler?
Northwind Health Company, LLC, NDC labeler code 82868. 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?
129 other product NDCs are listed under this name. See all Valsartan 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
valsartanValsartan 320 mg/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-39359746-0393-3059746-0393-3259746-0393-67+1 more
ValsartanValsartan 40 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-98942385-0989-0542385-0989-3042385-0989-68
ValsartanValsartan 80 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-99042385-0990-0542385-0990-3042385-0990-68+1 more
ValsartanValsartan 160 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-99142385-0991-0542385-0991-3042385-0991-68+1 more
ValsartanValsartan 320 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-99242385-0992-0542385-0992-3042385-0992-68+1 more
ValsartanValsartan 80 mg/1Tablet, Film coatedOralCoupler LLC67046-159667046-1596-03
ValsartanValsartan 320 mg/1Tablet, Film coatedOralCoupler LLC67046-157467046-1574-03
Valsartanvalsartan oralValsartan 4 mg/mLSolutionOralAdvagen Pharma Ltd72888-18472888-0184-1372888-0184-48
ValsartanValsartan 40 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-188270771-1882-03
ValsartanValsartan 80 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-188370771-1883-09

All 130 Valsartan NDCs

Other NDCs under ANDA 205536

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

FDA NDC Directory listings under ANDA 205536
ProductStrengthForm · routeLabelerProduct NDC
ValsartanValsartan 40 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-612
ValsartanValsartan 80 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-623
ValsartanValsartan 160 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-634
ValsartanValsartan 40 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-415
ValsartanValsartan 80 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-416
ValsartanValsartan 160 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-417
ValsartanValsartan 320 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-418
ValsartanValsartan 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1337
ValsartanValsartan 80 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3165
ValsartanValsartan 80 mg/1Tablet, Film coatedOralDirect_Rx72189-550

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