Home NDC 50268-187 Colchicine
Product NDC 50268-187
11-digit product format 502680187
Labeler code 50268
Product ID 50268-187_47e2f7f3-445a-dc42-e063-6294a90a4ba8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA204711
Marketing category ANDA
Marketing start 2021-09-15
Substance COLCHICINE
Active strength .6 mg/1
Pharmacologic classes Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A204711-001 COLCHICINE COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204711-001 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 · 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 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204711-001 COLCHICINE 0.6MG TABLET / ORAL 2016-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204711-001 COLCHICINE 0.6MG TABLET / ORAL 2016-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204711-001 COLCHICINE 0.6MG TABLET / ORAL AB 2016-09-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Colchicine
Listing expiration 2027-12-31 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 197541 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 50268-187-11 Colchicine 1 in 1 BLISTER PACK TABLET 1 4 50268-187-15 Colchicine 50 in 1 BOX TABLET 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-187 COLCHICINE TABLET [AVPAK] 3 Current NDC, Legacy NDC, 2 package rows 20240110_cc0e205a-697e-d47e-e053-2995a90a154e.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 · 2 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 50268-187-11 50268018711 1 in 1 BLISTER PACK Historical 50268-187-15 50268018715 50 BLISTER PACK in 1 BOX (50268-187-15) / 1 TABLET in 1 BLISTER PACK (50268-187-11) 50 blister pack 2021-09-15 0000-00-00 No No Current