FDA.reportPublic FDA data

Varenicline

Product NDC
49884-155
11-digit product format
498840155
Labeler code
49884
Product ID
49884-155_f703e1ca-8acc-4b42-ac8a-4a90b749cbe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA201785
Marketing category
ANDA
Marketing start
2021-09-21
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
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-155-76Varenicline56 in 1 BOTTLETABLET, FILM COATED5623

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-155-76EA - Each49884-155eaca344b-17e5-4ece-90c9-e918d7dde0f412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-155VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [ENDO USA, INC.]22Current NDC, Legacy NDC, 1 package rows20240523_9e5c0ef3-3179-4d7b-bc76-901473c73ce8.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) } PackGPCK9e5c0ef3-3179-4d7b-bc76-901473c73ce823
636671varenicline 0.5 MG Oral TabletPSN9e5c0ef3-3179-4d7b-bc76-901473c73ce823
636676varenicline 1 MG Oral TabletPSN9e5c0ef3-3179-4d7b-bc76-901473c73ce823
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN9e5c0ef3-3179-4d7b-bc76-901473c73ce823
636671varenicline 0.5 MG Oral TabletSCD9e5c0ef3-3179-4d7b-bc76-901473c73ce823
636676varenicline 1 MG Oral TabletSCD9e5c0ef3-3179-4d7b-bc76-901473c73ce823
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY9e5c0ef3-3179-4d7b-bc76-901473c73ce823
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY9e5c0ef3-3179-4d7b-bc76-901473c73ce823
749289varenicline first month of therapy PackSY9e5c0ef3-3179-4d7b-bc76-901473c73ce823
749289varenicline starting month Pack, 53 Oral TabletsSY9e5c0ef3-3179-4d7b-bc76-901473c73ce823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-155-764988401557656 TABLET, FILM COATED in 1 BOTTLE (49884-155-76) 2021-09-210000-00-00NoNoCurrent