Home NDC 60687-358 Colchicine
Product NDC 60687-358
11-digit product format 606870358
Labeler code 60687
Product ID 60687-358_352e69e1-762b-4e39-e063-6294a90ac4f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form CAPSULE
Route ORAL
Labeler American Health Packaging
Application NDA204820
Marketing category NDA
Marketing start 2018-04-04
Substance COLCHICINE
Active strength .6 mg/1
Pharmacologic classes Alkaloid [EPC], Alkaloids [CS]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204820-001 MITIGARE COLCHICINE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204820-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204820-001 8927607 2033-08-22 U-1020 2015-01-20 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 N204820-001 9789108 2033-08-22 U-1020 2017-11-13
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 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 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL AB RLD, RS 2014-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204820-001 MITIGARE 0.6MG CAPSULE / ORAL RLD, RS 2014-09-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204820-001 8927607 2033-08-22 U-1020 2015-01-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204820-001 9399036 2033-08-22 U-1020 2016-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204820-001 9555029 2033-08-22 U-1020 2017-02-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204820-001 9675613 2033-08-22 U-1020 2017-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204820-001 9789108 2033-08-22 U-1020 2017-11-13 5bbf6a4d5a75…
Additional Listing Data#
Finished product Yes
Brand name base Colchicine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLCHICINE .6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SML2Y3J35T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1550940 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 60687-358-25 Colchicine 30 in 1 BOX, UNIT-DOSE CAPSULE 30 7 60687-358-95 Colchicine 1 in 1 BLISTER PACK CAPSULE 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-358 COLCHICINE CAPSULE [AMERICAN HEALTH PACKAGING] 6 Current NDC, Legacy NDC, 2 package rows 20240502_2f5e24de-3956-4724-a5d7-fe81dcb07f6e.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 · 6 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-358-25 60687035825 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-358-25) / 1 CAPSULE in 1 BLISTER PACK (60687-358-95) 30 blister pack 2018-04-04 0000-00-00 No No Current 60687-358-95 60687035895 1 in 1 BLISTER PACK Historical