Home NDC 71921-307 Varenicline
Product NDC 71921-307
11-digit product format 719210307
Labeler code 71921
Product ID 71921-307_2b9c8b1e-6193-4d8e-9b50-6aca27294263
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Varenicline Tartrate
Dosage form KIT
Labeler Florida Pharmaceutical Products, LLC
Application ANDA219106
Marketing category ANDA
Marketing start 2024-11-01
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219106-001 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 A219106-002 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219106-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-10-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219106-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-10-29 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Varenicline
Listing expiration 2026-12-31 Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 82269ASB48 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 636671 Internal RxNorm lookup 636676 Internal RxNorm lookup 749289 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71921-307-51 Varenicline 1 in 1 CARTON KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71921-307 VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] 1 Current NDC, 1 package rows 20241107_2b9c8b1e-6193-4d8e-9b50-6aca27294263.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71921-307-51 71921030751 1 KIT in 1 CARTON (71921-307-51) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK 1 kit 2024-11-01 No No Current