Home NDC 60687-648 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 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 A201785-001 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 A201785-002 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11
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.
Product history page 1 of 2 · 66 observed 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 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL 2021-08-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL RS 2021-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2021-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2021-08-11 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201785-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2021-08-11 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201785-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB RS 2021-08-11 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Varenicline Active Ingredients# Ingredient, Strength table Ingredient Strength VARENICLINE TARTRATE 1 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 636676 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 60687-648-11 Varenicline 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4 60687-648-21 Varenicline 30 in 1 CARTON TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-648 VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 Current NDC, Legacy NDC, 2 package rows 20240406_16a03b5e-03e0-4b0b-92a4-aaf0669906f7.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-648-11 60687064811 1 in 1 BLISTER PACK Historical 60687-648-21 60687064821 30 BLISTER PACK in 1 CARTON (60687-648-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11) 30 blister pack 2022-02-11 2026-10-31 No No Current