FDA.reportPublic FDA data

varenicline

Product NDC
67877-743
11-digit product format
678770743
Labeler code
67877
Product ID
67877-743_be62466c-d597-473e-8796-76d3f5bf6885
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA214557
Marketing category
ANDA
Marketing start
2023-08-25
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

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
A214557-001VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2023-08-23
A214557-002VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2023-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214557-001AB
A214557-002AB

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
2026-08-01 22:54:322026-06A214557-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2023-08-23a50c72e98297…
2026-08-01 22:54:322026-06A214557-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2023-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214557-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214557-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
vareniclineVARENICLINE TARTRATEAvKARE0552d7ff-9fe8-9c9f-e063-6394a90a79fe2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214557
application number: ANDA214557
vareniclineVARENICLINE TARTRATEA-S Medication Solutions6351047a-9896-4a30-8e49-4d306ce9c9c02024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214557
application number: ANDA214557
vareniclineVARENICLINE TARTRATEA-S Medication Solutions2d5dfa6e-e69d-414a-8ff2-44714debbbe22024-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214557
application number: ANDA214557
vareniclineVARENICLINE TARTRATEMajor Pharmaceuticals1297c291-da28-4a73-9c28-d5adee36d7b72023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214557
application number: ANDA214557
vareniclineVARENICLINE TARTRATEAscend Laboratories, LLCe22e2a6a-66b4-459c-b978-51700e31a1a92023-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214557
application number: ANDA214557
ndc (product): 67877-743

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 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
636671Internal RxNorm lookup
636676Internal RxNorm lookup
749289Internal RxNorm lookup
749788Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e22e2a6a-66b4-459c-b978-51700e31a1a9Available 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
67877-743-95varenicline56 in 1 BOTTLETABLET, FILM COATED567

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-743-95EA - Each67877-743e99aa566-fbda-40b9-be6a-c6eaff855eb712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-743VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [ASCEND LABORATORIES, LLC]7Current NDC, 1 package rows20230928_e22e2a6a-66b4-459c-b978-51700e31a1a9.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) } PackGPCKe22e2a6a-66b4-459c-b978-51700e31a1a97
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKe22e2a6a-66b4-459c-b978-51700e31a1a97
636671varenicline 0.5 MG Oral TabletPSNe22e2a6a-66b4-459c-b978-51700e31a1a97
636676varenicline 1 MG Oral TabletPSNe22e2a6a-66b4-459c-b978-51700e31a1a97
749788varenicline 1 MG Oral Tablet 56 Count PackPSNe22e2a6a-66b4-459c-b978-51700e31a1a97
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNe22e2a6a-66b4-459c-b978-51700e31a1a97
636671varenicline 0.5 MG Oral TabletSCDe22e2a6a-66b4-459c-b978-51700e31a1a97
636676varenicline 1 MG Oral TabletSCDe22e2a6a-66b4-459c-b978-51700e31a1a97
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYe22e2a6a-66b4-459c-b978-51700e31a1a97
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYe22e2a6a-66b4-459c-b978-51700e31a1a97
749788varenicline 1 MG Oral Tablet 56 Count PackSYe22e2a6a-66b4-459c-b978-51700e31a1a97
749788varenicline continuing months of therapy PackSYe22e2a6a-66b4-459c-b978-51700e31a1a97
749289varenicline first month of therapy PackSYe22e2a6a-66b4-459c-b978-51700e31a1a97
749289varenicline starting month Pack, 53 Oral TabletsSYe22e2a6a-66b4-459c-b978-51700e31a1a97
636671varenicline 0.5 MG Oral TabletPSN2d5dfa6e-e69d-414a-8ff2-44714debbbe22
636671varenicline 0.5 MG Oral TabletSCD2d5dfa6e-e69d-414a-8ff2-44714debbbe22
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY2d5dfa6e-e69d-414a-8ff2-44714debbbe22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67877-743-956787707439556 TABLET, FILM COATED in 1 BOTTLE (67877-743-95) 2023-08-25NoNoCurrent