FDA.reportPublic FDA data

Varenicline

Product NDC
31722-678
11-digit product format
317220678
Labeler code
31722
Product ID
31722-678_09a2708f-ed1b-b986-e063-6394a90a8fb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214571
Marketing category
ANDA
Marketing start
2023-10-23
Substance
VARENICLINE TARTRATE
Active strength
.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Varenicline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636671, 636676, 749289, 749788

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-678-56Varenicline56 in 1 BOTTLETABLET, FILM COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-678-56EA - Each31722-678ce49c529-a922-4124-bc62-c6b92efd7b8b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-678VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20231109_7bd1abc8-2689-496b-b3f2-1cefe218ff5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636671varenicline 0.5 MG Oral TabletPSNd759167f-e0b2-46d5-a34a-3c8858e395902
636671varenicline 0.5 MG Oral TabletSCDd759167f-e0b2-46d5-a34a-3c8858e395902
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYd759167f-e0b2-46d5-a34a-3c8858e395902
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCK7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
636671varenicline 0.5 MG Oral TabletPSN7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
636676varenicline 1 MG Oral TabletPSN7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
749788varenicline 1 MG Oral Tablet 56 Count PackPSN7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
636671varenicline 0.5 MG Oral TabletSCD7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
636676varenicline 1 MG Oral TabletSCD7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
749788varenicline 1 MG Oral Tablet 56 Count PackSY7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
749788varenicline continuing months of therapy PackSY7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
749289varenicline first month of therapy PackSY7bd1abc8-2689-496b-b3f2-1cefe218ff5a1
749289varenicline starting month Pack, 53 Oral TabletsSY7bd1abc8-2689-496b-b3f2-1cefe218ff5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-678-563172206785656 TABLET, FILM COATED in 1 BOTTLE (31722-678-56) 2023-10-23NoNoCurrent