What is NDC 46708-046?

46708-046 is the product NDC for Valsartan, Valsartan 160 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-046 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-046Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0046Add 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
46708-046-10	46708004610	100 TABLET in 1 CARTON (46708-046-10)Marketed from Jan 6, 2015
46708-046-30	46708004630	30 TABLET in 1 BOTTLE (46708-046-30)Marketed from Jan 6, 2015
46708-046-71	46708004671	500 TABLET in 1 BOTTLE (46708-046-71)Marketed from Jan 6, 2015
46708-046-90	46708004690	90 TABLET in 1 BOTTLE (46708-046-90)Marketed from Jan 6, 2015
46708-046-91	46708004691	1000 TABLET in 1 BOTTLE (46708-046-91)Marketed from Jan 6, 2015

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
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091367
Marketing start: Jan 6, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 46708-046_3c6999e0-a1f1-40f0-8a6e-f3513410fd5dSPL ID 3c6999e0-a1f1-40f0-8a6e-f3513410fd5dSPL set ID 6e2cd953-88bf-4094-8ba8-2c9ba020f4d7RxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0346708045302, 0346708047306, 0346708046309, 0346708044305
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

N446708004610 followed by a unit qualifier and the quantity

Package 46708-0046-10. 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 Jan 12, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Valsartan tablets is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension , to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Treatment of heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure (1.2) 1.1 Hypertension Valsartan tablets 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 antihyperte…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-046

What is NDC 46708-046?: 46708-046 is the product NDC for Valsartan, Valsartan 160 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 091367

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

FDA NDC Directory listings under ANDA 091367
Product	Strength	Form · route	Labeler	Product NDC
Valsartan	Valsartan 40 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-044
Valsartan	Valsartan 80 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-045
Valsartan	Valsartan 320 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-047
Valsartan	Valsartan 40 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-044
Valsartan	Valsartan 80 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-045
Valsartan	Valsartan 160 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-046
Valsartan	Valsartan 320 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-047