What is NDC 70771-1774?

70771-1774 is the product NDC for Varenicline, Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Varenicline?

56 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Varenicline NDC 70771-1774 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1774Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1774Add 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
70771-1774-6	7077117740670771177406	56 TABLET, FILM COATED in 1 BOTTLE (70771-1774-6)Marketed from Jun 13, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Varenicline
Generic name (nonproprietary): varenicline
Active ingredients: Varenicline tartrate — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216723
Marketing start: Jun 13, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers: Product ID 70771-1774_df89bfa8-f749-4840-a207-6499b82516f5SPL ID df89bfa8-f749-4840-a207-6499b82516f5SPL set ID 481b94af-ee34-44be-8ca1-b2415525efacRxCUI 636671, 636676UNII 82269ASB48
Pharmacologic class: Cholinergic Receptor Agonist; Partial Cholinergic Nicotinic Agonist

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

N470771177406 followed by a unit qualifier and the quantity

Package 70771-1774-06. 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 28, 2023.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1774

What is NDC 70771-1774?: 70771-1774 is the product NDC for Varenicline, Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Varenicline.
What is the active ingredient?: Varenicline tartrate.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Varenicline?: 56 other product NDCs are listed under this name. See all Varenicline 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 Varenicline NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Vareniclinevarenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4647	70518-4647-00
Varenicline	Varenicline tartrate .5 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-077	60290-0077-0160290-0077-02
Varenicline	Varenicline tartrate 1 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-078	60290-0078-0160290-0078-0260290-0078-03
varenicline	—	Kit	Umedica Laboratories USA Inc.	60290-095	60290-0095-01
Vareniclinevarenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-893	60687-0893-21
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-417	59651-0417-56
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-418	59651-0418-5559651-0418-56
Varenicline	—	Kit	Aurobindo Pharma Limited	59651-451	59651-0451-53
Vareniclinevarenicline tartrate	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-808	10135-0808-56
Vareniclinevarenicline tartrate	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Marlex Pharmaceuticals, Inc.	10135-809	10135-0809-56

All 57 Varenicline NDCs

Other NDCs under ANDA 216723

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

FDA NDC Directory listings under ANDA 216723
Product	Strength	Form · route	Labeler	Product NDC
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1613
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1614
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1773