Home NDC 0591-3720 Tranexamic Acid
Product NDC 0591-3720
11-digit product format 005913720
Labeler code 0591
Product ID 0591-3720_b97d11de-dcc7-4b90-8f6a-c46848eddab3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranexamic Acid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA202093
Marketing category ANDA
Marketing start 2013-01-03
Substance TRANEXAMIC ACID
Active strength 650 mg/1
Pharmacologic classes Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0591-3720 0591-3720-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202093-001 TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202093-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202093-001 TRANEXAMIC ACID 650MG TABLET / ORAL AB 2012-12-27 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tranexamic Acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANEXAMIC ACID 650 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6T84R30KC1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 883826 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 0591-3720-10 Tranexamic Acid 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 18 0591-3720-30 Tranexamic Acid 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRANEXAMIC ACID ACTIVE INGREDIENT 6T84R30KC1 TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 TRANEXAMIC ACID ACTIVE MOIETY 6T84R30KC1 TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 905HNO1SIH TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 10 TRANEXAMIC ACID ACTIVE INGREDIENT 6T84R30KC1 TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TRANEXAMIC ACID ACTIVE MOIETY 6T84R30KC1 TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 905HNO1SIH TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM TRANEXAMIC ACID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3720 TRANEXAMIC ACID TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20210204_3f07e93b-3568-487e-894f-8f90e5a0960a.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 · 3 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 0591-3720-10 00591372010 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-10) 2013-01-03 0000-00-00 No No Current 0591-3720-30 00591372030 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-30) 2013-01-03 0000-00-00 No No Current