Home NDC 49884-156 Varenicline
Product NDC 49884-156
11-digit product format 498840156
Labeler code 49884
Product ID 49884-156_f703e1ca-8acc-4b42-ac8a-4a90b749cbe7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name varenicline tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Par Health USA, LLC
Application ANDA201785
Marketing category ANDA
Marketing start 2021-09-21
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
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-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
Listing expiration 2027-12-31 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 · 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 49884-156-76 Varenicline 56 in 1 BOTTLE TABLET, FILM COATED 56 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-156 VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [ENDO USA, INC.] 22 Current NDC, Legacy NDC, 1 package rows 20240523_9e5c0ef3-3179-4d7b-bc76-901473c73ce8.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 Marketing start Marketing end Sample Exclude flag Status 49884-156-76 49884015676 56 TABLET, FILM COATED in 1 BOTTLE (49884-156-76) 2021-09-21 0000-00-00 No No Current