FDA.reportPublic FDA data

Varenicline

Product NDC
60687-648
11-digit product format
606870648
Labeler code
60687
Product ID
60687-648_4599c6fb-66cd-c7fe-e063-6294a90ac97f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA201785
Marketing category
ANDA
Marketing start
2022-02-11
Marketing end
2026-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Varenicline

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636676

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
60687-648-11Varenicline1 in 1 BLISTER PACKTABLET, FILM COATED14
60687-648-21Varenicline30 in 1 CARTONTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-648-11EA - Each60687-648645523aa-51f3-47a6-9a3e-86ad72cf6cbe12022-02-07
60687-648-21EA - Each60687-648acbf1b48-6ccb-40eb-98bc-dd49adb1b31f12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-648VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 2 package rows20240406_16a03b5e-03e0-4b0b-92a4-aaf0669906f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636676varenicline 1 MG Oral TabletPSN16a03b5e-03e0-4b0b-92a4-aaf0669906f74
636676varenicline 1 MG Oral TabletSCD16a03b5e-03e0-4b0b-92a4-aaf0669906f74
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY16a03b5e-03e0-4b0b-92a4-aaf0669906f74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-648-11606870648111 in 1 BLISTER PACKHistorical
60687-648-216068706482130 BLISTER PACK in 1 CARTON (60687-648-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11) 30 blister pack2022-02-112026-10-31NoNoCurrent