FDA.reportPublic FDA data

varenicline

Product NDC
75834-335
11-digit product format
758340335
Labeler code
75834
Product ID
75834-335_077ec752-4145-4592-9ee1-6fdc9a04795a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Nivagen Pharmaceuticals Inc.
Application
ANDA217115
Marketing category
ANDA
Marketing start
2026-03-02
Substance
VARENICLINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
varenicline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636671, 636676, 749289

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-335-27varenicline14 in 1 BLISTER PACKTABLET, FILM COATED141
75834-335-27varenicline4 in 1 CARTONTABLET, FILM COATED41
75834-335-28varenicline56 in 1 BOTTLETABLET, FILM COATED561

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK077ec752-4145-4592-9ee1-6fdc9a04795a1
636671varenicline 0.5 MG Oral TabletPSN077ec752-4145-4592-9ee1-6fdc9a04795a1
636676varenicline 1 MG Oral TabletPSN077ec752-4145-4592-9ee1-6fdc9a04795a1
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN077ec752-4145-4592-9ee1-6fdc9a04795a1
636671varenicline 0.5 MG Oral TabletSCD077ec752-4145-4592-9ee1-6fdc9a04795a1
636676varenicline 1 MG Oral TabletSCD077ec752-4145-4592-9ee1-6fdc9a04795a1
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY077ec752-4145-4592-9ee1-6fdc9a04795a1
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY077ec752-4145-4592-9ee1-6fdc9a04795a1
749289varenicline first month of therapy PackSY077ec752-4145-4592-9ee1-6fdc9a04795a1
749289varenicline starting month Pack, 53 Oral TabletsSY077ec752-4145-4592-9ee1-6fdc9a04795a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75834-335-27758340335274 BLISTER PACK in 1 CARTON (75834-335-27) / 14 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2026-03-02NoNoCurrent
75834-335-287583403352856 TABLET, FILM COATED in 1 BOTTLE (75834-335-28) 2026-03-02NoNoCurrent