Home NDC 33342-337 Apixaban
Product NDC 33342-337
11-digit product format 333420337
Labeler code 33342
Product ID 33342-337_396912c0-9f68-47ed-ba3f-8d9ace755a48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Apixaban
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA210067
Marketing category ANDA
Marketing start 2025-02-27
Substance APIXABAN
Active strength 2.5 mg/1
Pharmacologic classes Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210067-001 APIXABAN APIXABAN 2.5MG TABLET / ORAL 2025-02-27 A210067-002 APIXABAN APIXABAN 5MG TABLET / ORAL 2025-02-27
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 A210067-001 APIXABAN 2.5MG TABLET / ORAL 2025-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210067-002 APIXABAN 5MG TABLET / ORAL 2025-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210067-001 APIXABAN 2.5MG TABLET / ORAL 2025-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210067-002 APIXABAN 5MG TABLET / ORAL 2025-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210067-001 APIXABAN 2.5MG TABLET / ORAL 2025-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210067-002 APIXABAN 5MG TABLET / ORAL 2025-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210067-001 APIXABAN 2.5MG TABLET / ORAL AB 2025-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210067-002 APIXABAN 5MG TABLET / ORAL AB 2025-02-27 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210067-001 APIXABAN 2.5MG TABLET / ORAL 2025-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210067-002 APIXABAN 5MG TABLET / ORAL 2025-02-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210067-001 AB 1 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210067-002 AB 1 fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base Apixaban
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APIXABAN 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3Z9Y7UWC1J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1364435 Internal RxNorm lookup 1364445 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 33342-337-09 Apixaban 60 in 1 BOTTLE TABLET, FILM COATED 60 1 33342-337-12 Apixaban 10 in 1 CARTON TABLET, FILM COATED 10 1 33342-337-12 Apixaban 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 33342-337-15 Apixaban 500 in 1 BOTTLE TABLET, FILM COATED 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-337 APIXABAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20250427_396912c0-9f68-47ed-ba3f-8d9ace755a48.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Apixaban APIXABAN Macleods Pharmaceuticals Limited 396912c0-9f68-47ed-ba3f-8d9ace755a48 2025-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210067 application number: ANDA210067 ndc (product): 33342-337
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-337-09 33342033709 60 TABLET, FILM COATED in 1 BOTTLE (33342-337-09) 2025-02-27 No No Current 33342-337-12 33342033712 10 BLISTER PACK in 1 CARTON (33342-337-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2025-02-27 No No Current 33342-337-15 33342033715 500 TABLET, FILM COATED in 1 BOTTLE (33342-337-15) 2025-02-27 No No Current