Home NDC 71610-494 Colchicine
Product NDC 71610-494
11-digit product format 716100494
Labeler code 71610
Product ID 71610-494_543ae21a-60f3-49e2-8bad-b9ee0f412235
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA210425
Marketing category ANDA
Marketing start 2020-02-05
Substance COLCHICINE
Active strength .6 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
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 71610-494-03 Colchicine 9 in 1 BOTTLE TABLET, FILM COATED 9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-494 COLCHICINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20201218_b310c57c-9192-4dc8-b76f-2c1982941caf.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 Marketing start Marketing end Sample Exclude flag Status 71610-494-03 71610049403 9 TABLET, FILM COATED in 1 BOTTLE (71610-494-03) 2020-11-17 0000-00-00 No No Current