FDA.reportPublic FDA data

VARENICLINE

Product NDC
60290-077
Requested package NDC
60290-077-02
11-digit product format
602900077
Labeler code
60290
Product ID
60290-077_48e02d69-578d-6c15-e063-6394a90ade7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARENICLINE
Dosage form
TABLET
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA218985
Marketing category
ANDA
Marketing start
2026-01-09
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218985-001VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2026-01-09
A218985-002VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2026-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218985-001AB
A218985-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218985-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2026-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218985-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2026-01-09011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218985-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2026-01-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218985-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2026-01-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218985-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218985-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218985-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218985-002AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82269ASB48Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
636671Internal RxNorm lookup
636676Internal RxNorm lookup
749289Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2e57493-d099-4055-8e92-67611c8d20f4Available on FDA.report

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
60290-077-01VARENICLINE56 in 1 BOTTLETABLET562
60290-077-02VARENICLINE60 in 1 CARTONTABLET602
60290-077-02VARENICLINE1 in 1 BLISTER PACKTABLET12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VARENICLINEVARENICLINEUmedica Laboratories USA Inc.f2e57493-d099-4055-8e92-67611c8d20f42026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218985
application number: ANDA218985
ndc (package): 60290-077-02
ndc (product): 60290-077
ndc11 (package): 60290007702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636671varenicline 0.5 MG Oral TabletPSNf2e57493-d099-4055-8e92-67611c8d20f42
636676varenicline 1 MG Oral TabletPSNf2e57493-d099-4055-8e92-67611c8d20f42
636671varenicline 0.5 MG Oral TabletSCDf2e57493-d099-4055-8e92-67611c8d20f42
636676varenicline 1 MG Oral TabletSCDf2e57493-d099-4055-8e92-67611c8d20f42
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYf2e57493-d099-4055-8e92-67611c8d20f42
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYf2e57493-d099-4055-8e92-67611c8d20f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60290-077-026029000770260 BLISTER PACK in 1 CARTON (60290-077-02) / 1 TABLET in 1 BLISTER PACK60 blister pack2026-01-09NoNoCurrent