Colchicine

Product NDC
60687-389
11-digit product format
606870389
Labeler code
60687
Product ID
60687-389_e0caa014-f9f8-c59c-e053-2a95a90a0f13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
NDA022352
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-08-01
Marketing end
0000-00-00
Substance
COLCHICINE
Active strength
1 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60687-389DDiscontinued by firm2026-08-11
excluded packagepackage60687-38960687-389-21DDiscontinued by firm2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60687-389-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60687-389-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60687-389-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60687-389-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60687-389-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60687-389-21cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022352-001COLCRYSCOLCHICINE0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-07-29

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022352-00179646472028-10-06U-10072011-06-24
N022352-00179646482028-10-06U-11612011-06-24
N022352-00179819382028-10-06U-11662011-07-22
N022352-00180932962028-10-06U-10072012-01-13
N022352-00180932972028-10-06U-11612012-01-13
N022352-00180932982028-10-06U-11162012-01-13
N022352-00180976552028-10-06U-10202012-01-27
N022352-00184153952028-10-06U-10072013-05-08
N022352-00184153962028-10-06U-10072013-05-08
N022352-00176190042028-12-03U-1020
N022352-00179357312028-12-03U-11162011-06-24
N022352-00176017582029-02-10U-1007
N022352-00178206812029-02-17U-1020
N022352-00179065192029-02-17U-1116
N022352-00179152692029-02-17U-1007
N022352-00184407212029-02-17U-10072013-06-10
N022352-00184407222029-02-17U-10202013-06-10

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022352-001COLCRYS0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022352-001COLCRYS0.6MGTABLET / ORALRLD2009-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022352-001COLCRYS0.6MGTABLET / ORALABRLD, RS2009-07-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05N022352-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022352-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022352-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022352-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022352-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022352-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022352-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022352-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022352-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022352-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022352-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022352-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022352-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022352-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022352-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022352-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022352-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022352-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022352-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022352-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022352-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022352-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022352-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022352-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022352-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022352-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022352-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 18 · 697 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022352-00179646472028-10-06U-10072011-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00179646482028-10-06U-11612011-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00179819382028-10-06U-11662011-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00180932962028-10-06U-10072012-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00180932972028-10-06U-11612012-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00180932982028-10-06U-11162012-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00180976552028-10-06U-10202012-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00184153952028-10-06U-10072013-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00184153962028-10-06U-10072013-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00176190042028-12-03U-1020011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00179357312028-12-03U-11162011-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00176017582029-02-10U-1007011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00178206812029-02-17U-1020011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00179065192029-02-17U-1116011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00179152692029-02-17U-1007011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00184407212029-02-17U-10072013-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022352-00184407222029-02-17U-10202013-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00179646472028-10-06U-10072011-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00179646482028-10-06U-11612011-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00179819382028-10-06U-11662011-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00180932962028-10-06U-10072012-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00180932972028-10-06U-11612012-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00180932982028-10-06U-11162012-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00180976552028-10-06U-10202012-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00184153952028-10-06U-10072013-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00184153962028-10-06U-10072013-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00176190042028-12-03U-102031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00179357312028-12-03U-11162011-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00176017582029-02-10U-100731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00178206812029-02-17U-102031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00179065192029-02-17U-111631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00179152692029-02-17U-100731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00184407212029-02-17U-10072013-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022352-00184407222029-02-17U-10202013-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022352-00179646472028-10-06U-10072011-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022352-00179646482028-10-06U-11612011-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022352-00179819382028-10-06U-11662011-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022352-00180932962028-10-06U-10072012-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022352-00180932972028-10-06U-11612012-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022352-00180932982028-10-06U-11162012-01-136a471c1ec25d…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-389-11EA - Each60687-3897a6ae7db-cc36-4bed-ab15-18dac608cfa112018-09-05
60687-389-21EA - Each60687-389945cf271-07ef-4328-84cf-3b65cc0e011612018-09-05

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLCHICINECOLCHICINEdirect rxc7d013b7-0a67-0953-e053-2a95a90ac47c2025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 022352
application number: NDA022352
ColchicineCOLCHICINEBryant Ranch Prepacka15538ee-d1eb-4118-97c3-53748cea012a2024-05-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 022352
application number: NDA022352
ColchicineCOLCHICINEBryant Ranch Prepackdf1dd89a-a1b3-48e8-b0e8-ad71b4cb0c962024-01-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 022352
application number: NDA022352
ColchicineCOLCHICINEBryant Ranch Prepack5e5d9488-d9d0-4b37-b535-941d66c3430d2024-01-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 022352
application number: NDA022352
ColcrysCOLCHICINEProficient Rx LPd6adc880-5499-4691-93f3-27c87902d5fc2022-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 022352
application number: NDA022352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-389-216068703892130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-389-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-389-11) 30 blister pack2018-08-010000-00-00NoNoCurrent