Home NDC 14445-150 apixaban
Product NDC 14445-150
11-digit product format 144450150
Labeler code 14445
Product ID 14445-150_6a6e421b-6ed3-403c-b07d-09dbbd6a487c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name apixaban
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Indoco Remedies Limited
Application ANDA209898
Marketing category ANDA
Marketing start 2020-09-16
Substance APIXABAN
Active strength 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 A209898-001 APIXABAN APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 A209898-002 APIXABAN APIXABAN 5MG TABLET / ORAL AB 2020-09-11
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 · 74 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 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209898-001 APIXABAN 2.5MG TABLET / ORAL AB 2020-09-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209898-002 APIXABAN 5MG TABLET / ORAL AB 2020-09-11 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base apixaban
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APIXABAN 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 14445-150-05 apixaban 500 in 1 BOTTLE TABLET, FILM COATED 500 7 14445-150-10 apixaban 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7 14445-150-18 apixaban 180 in 1 BOTTLE TABLET, FILM COATED 180 7 14445-150-60 apixaban 60 in 1 BOTTLE TABLET, FILM COATED 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14445-150 APIXABAN TABLET, FILM COATED [INDOCO REMEDIES LIMITED ] 7 Current NDC, Legacy NDC, 4 package rows 20210615_095a08ac-cf0e-497e-a682-ddef38d6b29c.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.
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 14445-150-05 14445015005 500 TABLET, FILM COATED in 1 BOTTLE (14445-150-05) 2020-09-16 0000-00-00 No No Current 14445-150-10 14445015010 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-150-10) 2020-09-16 0000-00-00 No No Current 14445-150-18 14445015018 180 TABLET, FILM COATED in 1 BOTTLE (14445-150-18) 2020-09-16 0000-00-00 No No Current 14445-150-60 14445015060 60 TABLET, FILM COATED in 1 BOTTLE (14445-150-60) 2020-09-16 0000-00-00 No No Current