What is NDC 50090-7997?

50090-7997 is the product NDC for Varenicline, Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.

A-S Medication Solutions, NDC labeler code 50090. 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 50090-7997 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-7997Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-7997Add 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
50090-7997-0	5009079970050090799700	56 TABLET, FILM COATED in 1 BOTTLE (50090-7997-0)Marketed from Jun 17, 2026

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: A-S Medication SolutionsNDC labeler code 50090
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211862
Marketing start: Jan 9, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers: Product ID 50090-7997_d641118b-9558-46fc-b310-923863d26825SPL ID d641118b-9558-46fc-b310-923863d26825SPL set ID 8a06d177-0e62-457d-b0c8-47f60a313a1cRxCUI 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

N450090799700 followed by a unit qualifier and the quantity

Package 50090-7997-00. 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 Jun 22, 2026.

Indications (excerpt from the label)

Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are nicotinic receptor partial agonist indicated for use as an aid to smoking-cessation treatment. ( 1 and 2.1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-7997

What is NDC 50090-7997?: 50090-7997 is the product NDC for Varenicline, Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. 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?: A-S Medication Solutions, NDC labeler code 50090. 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 211862

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

FDA NDC Directory listings under ANDA 211862
Product	Strength	Form · route	Labeler	Product NDC
Varenicline	Varenicline tartrate .5 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	70748-127
Varenicline	Varenicline tartrate 1 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	70748-128
Varenicline Tartrate	—	Kit	Lupin Pharmaceuticals, Inc.	70748-125