Home NDC 50090-8088 Varenicline
Product NDC 50090-8088
11-digit product format 500908088
Labeler code 50090
Product ID 50090-8088_d5b22610-aabf-410e-8777-3951311e4ce3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Varenicline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA215048
Marketing category ANDA
Marketing start 2024-12-10
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 44 .
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 A215048-001 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 A215048-002 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09
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 2026-10-15 13:18:30 2026-09 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Varenicline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARENICLINE TARTRATE .5 mg/1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Varenicline VARENICLINE Macleods Pharmaceuticals Limited c325d582-8f43-40ea-b348-87837de97a07 2025-09-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 215048 application number: ANDA215048
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-8088-0 50090808800 56 TABLET, FILM COATED in 1 BOTTLE (50090-8088-0) 2026-09-21 No No Current