Home NDC 72789-572 Colchicine
Product NDC 72789-572
11-digit product format 727890572
Labeler code 72789
Product ID 72789-572_5245af45-77cc-c95f-e063-6294a90a24f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA208993
Marketing category ANDA
Marketing start 2021-08-13
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 A208993-001 COLCHICINE COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208993-001 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 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208993-001 COLCHICINE 0.6MG TABLET / ORAL AB 2021-08-13 a50c72e98297…
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 72789-572-30 Colchicine 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-572-30 72789057230 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-572-30) 2026-05-20 No No Current