FDA.reportPublic FDA data

varenicline

Product NDC
42291-927
11-digit product format
422910927
Labeler code
42291
Product ID
42291-927_48bfad2d-97de-5ed7-e063-6394a90a2e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA214557
Marketing category
ANDA
Marketing start
2023-09-14
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
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 TARTRATE.5 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-927-56varenicline56 in 1 BOTTLETABLET, FILM COATED562

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-927-56EA - Each42291-927292fb654-daf5-467b-9525-4cee9f9579f412023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-927VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [AVKARE]1Current NDC, 1 package rows20230915_0552d7ff-9fe8-9c9f-e063-6394a90a79fe.zip

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) } PackGPCK0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
636671varenicline 0.5 MG Oral TabletPSN0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
636676varenicline 1 MG Oral TabletPSN0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
636671varenicline 0.5 MG Oral TabletSCD0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
636676varenicline 1 MG Oral TabletSCD0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
749289varenicline first month of therapy PackSY0552d7ff-9fe8-9c9f-e063-6394a90a79fe2
749289varenicline starting month Pack, 53 Oral TabletsSY0552d7ff-9fe8-9c9f-e063-6394a90a79fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-927-564229109275656 TABLET, FILM COATED in 1 BOTTLE (42291-927-56) 2023-09-14NoNoCurrent