What is NDC 70954-310?

70954-310 is the product NDC for Valsartan, Valsartan 4 mg/mL solution, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valsartan NDC 70954-310 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0310Add 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 NDC	11-digit (billing)	Package	Copy
70954-310-10	70954031010	120 mL in 1 BOTTLE, PLASTIC (70954-310-10)Marketed from Nov 2, 2021
70954-310-20	70954031020	473 mL in 1 BOTTLE, PLASTIC (70954-310-20)Marketed from Nov 2, 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 — 4 mg/mL
Dosage form: Solution
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214102
Marketing start: Nov 2, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 70954-310_12e344cb-87c4-44a1-a59a-c6bcaaa6cb2cSPL ID 12e344cb-87c4-44a1-a59a-c6bcaaa6cb2cSPL set ID 959b6790-feb7-45a9-9ea4-0ee1a7fce048RxCUI 1996254UNII 80M03YXJ7IUPC 0370954310105, 0370954310204
Pharmacologic class: Angiotensin 2 Receptor Blocker

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

N470954031010 followed by a unit qualifier and the quantity

Package 70954-0310-10. 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 Sep 18, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension in adults and children six years and older, to lower blood pressure. 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); Valsartan oral solution significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets (1.2) Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; Valsartan oral solution reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets (1.3) 1.1 Hypertension Val…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-310

What is NDC 70954-310?: 70954-310 is the product NDC for Valsartan, Valsartan 4 mg/mL solution, listed with the FDA by ANI 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?: ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
valsartan	Valsartan 320 mg/1	TabletOral	Jubilant Cadista Pharmaceuticals Inc.	59746-393	59746-0393-3059746-0393-3259746-0393-67+1 more
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-989	42385-0989-0542385-0989-3042385-0989-68
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-990	42385-0990-0542385-0990-3042385-0990-68+1 more
Valsartan	Valsartan 160 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-991	42385-0991-0542385-0991-3042385-0991-68+1 more
Valsartan	Valsartan 320 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-992	42385-0992-0542385-0992-3042385-0992-68+1 more
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1596	67046-1596-03
Valsartan	Valsartan 320 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1574	67046-1574-03
Valsartanvalsartan oral	Valsartan 4 mg/mL	SolutionOral	Advagen Pharma Ltd	72888-184	72888-0184-1372888-0184-48
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1882	70771-1882-03
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1883	70771-1883-09

All 130 Valsartan NDCs

Other NDCs under ANDA 214102

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

FDA NDC Directory listings under ANDA 214102
Product	Strength	Form · route	Labeler	Product NDC
Valsartan	Valsartan 4 mg/mL	SolutionOral	Lifsa Drugs LLC	72336-910