NDC codes

FDA NDC Directory
Product NDC (as listed)33342-062Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0062Add 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
33342-062-073334200620730 TABLET, FILM COATED in 1 BOTTLE (33342-062-07)Marketed from Sep 19, 2016
33342-062-44333420062441000 TABLET, FILM COATED in 1 BOTTLE (33342-062-44)Marketed from Sep 19, 2016

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 — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202696
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 33342-062_2481f60c-17b4-4b6f-946f-92c7928215b0SPL ID 2481f60c-17b4-4b6f-946f-92c7928215b0SPL set ID 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46RxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0333342062079, 0333342063106, 0333342064103, 0333342065100

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

N433342006207 followed by a unit qualifier and the quantity

Package 33342-0062-07. 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 tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension , to lower blood pressure in adults and children 6 years 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,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-062

What is NDC 33342-062?
33342-062 is the product NDC for Valsartan, Valsartan 40 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 202696

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

FDA NDC Directory listings under ANDA 202696
ProductStrengthForm · routeLabelerProduct NDC
ValsartanValsartan 80 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-063
ValsartanValsartan 160 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-064
ValsartanValsartan 320 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-065
ValsartanValsartan 320 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4130
ValsartanValsartan 160 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-456
ValsartanValsartan 320 mg/1Tablet, Film coatedOralProficient Rx LP71205-301
ValsartanValsartan 80 mg/1Tablet, Film coatedOralDirect_Rx72189-049

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