Home NDC 0904-7120 Colchicine
Product NDC 0904-7120
11-digit product format 009047120
Labeler code 0904
Product ID 0904-7120_7542e468-1c98-45ea-9aa2-153bdb40b663
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA210425
Marketing category ANDA
Marketing start 2020-05-13
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 A210425-001 COLCHICINE COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210425-001 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 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210425-001 COLCHICINE 0.6MG TABLET / ORAL AB 2020-02-05 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 0904-7120-04 Colchicine 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4 0904-7120-04 Colchicine 30 in 1 CARTON TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7120 COLCHICINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 2 package rows 20250207_9e7c8f65-4722-4187-9014-8fa81eb5681e.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.
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 0904-7120-04 00904712004 30 BLISTER PACK in 1 CARTON (0904-7120-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK 30 blister pack 2020-05-13 0000-00-00 No No Current