Colchicine

Product NDC
67296-1708
11-digit product format
672961708
Labeler code
67296
Product ID
67296-1708_b8dfb680-8a99-5315-e053-2995a90aa59d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA022352
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-07-01
Marketing end
0000-00-00
Substance
COLCHICINE
Active strength
1 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct67296-1708IInactivated by FDA2026-08-11
excluded packagepackage67296-170867296-1708-3IInactivated by FDA2026-08-11

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1708-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1708-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1708-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1708-31332a3947898…d4bfe170f9cd…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51989a2b-944a-b31f-835e-469c133570adProduct name220250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2Product name220250214
14efe2b0-2695-4943-8b2f-24f519c99fedProduct name120231023
bf4e8ffd-8f13-3050-5248-581676b7ea42Product name620221214
987af351-b977-4822-ac44-c76d29e24e78Product name120190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1708-32024-08-02C16284748780-1f386c64a-28f2-0266-e053-dadaa90a7c1aColchicine 0.6mg
67296-1708-32023-01-30C16284748780-1f386c64a-28f2-0266-e053-dadaa90a7c1aColchicine 0.6mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1708-3Colchicine3 in 1 BOTTLETABLET, FILM COATED37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1708COLCHICINE TABLET, FILM COATED [REDPHARM DRUG, INC.]7Legacy NDC, 1 package rows20240805_96ca32da-68cc-d757-e053-2995a90a76d8.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN96ca32da-68cc-d757-e053-2995a90a76d87
197541colchicine 0.6 MG Oral TabletSCD96ca32da-68cc-d757-e053-2995a90a76d87
197541colchicine 600 MCG Oral TabletSY96ca32da-68cc-d757-e053-2995a90a76d87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1708-3672961708033 TABLET, FILM COATED in 1 BOTTLE (67296-1708-3) 2019-11-010000-00-00NoNoCurrent