NDC codes

FDA NDC Directory
Product NDC (as listed)50228-134Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0134Add 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
50228-134-1050228013410502280134101000 TABLET in 1 BOTTLE (50228-134-10)Marketed from Oct 27, 2021
50228-134-30502280134305022801343030 TABLET in 1 BOTTLE (50228-134-30)Marketed from Oct 27, 2021

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 — 80 mg/1
Dosage form
Tablet
Route
Oral
Labeler
ScieGen Pharmaceuticals, INC.NDC labeler code 50228
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204038
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 50228-134_32318eee-6c28-4ec7-8a20-2089c6bd33ebSPL ID 32318eee-6c28-4ec7-8a20-2089c6bd33ebSPL set ID 1a8af3d9-4053-4233-82a7-e8c7bc9e302fRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0350228134309, 0350228133302, 0350228135108, 0350228133906, 0350228132909, 0350228135306, 0350228134903, 0350228132305

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

N450228013410 followed by a unit qualifier and the quantity

Package 50228-0134-10. 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 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 blood p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50228-134

What is NDC 50228-134?
50228-134 is the product NDC for Valsartan, Valsartan 80 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals, INC.. 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?
ScieGen Pharmaceuticals, INC., NDC labeler code 50228. 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?
130 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 131 Valsartan NDCs

Other NDCs under ANDA 204038

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

FDA NDC Directory listings under ANDA 204038
ProductStrengthForm · routeLabelerProduct NDC
ValsartanValsartan 320 mg/1TabletOralScieGen Pharmaceuticals, INC.50228-132
ValsartanValsartan 160 mg/1TabletOralScieGen Pharmaceuticals, INC.50228-133
ValsartanValsartan 40 mg/1TabletOralScieGen Pharmaceuticals, INC.50228-135

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