Home NDC 42292-054-03 Colchicine
Product NDC 42292-054
Requested package NDC 42292-054-03
11-digit product format 422920054
Labeler code 42292
Product ID 42292-054_e2b0862b-5cc1-d072-e053-2995a90a6ece
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA209470
Marketing category ANDA
Marketing start 2020-04-30
Marketing end 2030-01-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 2 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 42292-054 42292-054-03 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42292-054 42292-054-03 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A209470-001 COLCHICINE COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209470-001 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.
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 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209470-001 COLCHICINE 0.6MG TABLET / ORAL 2019-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209470-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-09-16 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42292-054 COLCHICINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 11 Legacy NDC 20240618_5d8d511a-0851-4d0a-a01a-f43398b63a06.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42292-054-03 42292005403 30 BLISTER PACK in 1 CARTON (42292-054-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-054-01) 30 blister pack 2020-04-30 2030-01-31 No No Current