Home NDC 0254-0460 Colchicine
Product NDC 0254-0460
11-digit product format 002540460
Labeler code 0254
Product ID 0254-0460_976af5c9-3fa5-4a35-b849-6cc69b892c1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form CAPSULE
Route ORAL
Labeler Par Health USA, LLC
Application ANDA208678
Marketing category ANDA
Marketing start 2023-11-01
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 A208678-001 COLCHICINE COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208678-001 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 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2018-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208678-001 COLCHICINE 0.6MG CAPSULE / ORAL 2018-11-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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 1550940 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 0254-0460-01 Colchicine 100 in 1 BOTTLE CAPSULE 100 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0254-0460 COLCHICINE CAPSULE [ENDO USA, INC.] 19 Current NDC, 1 package rows 20250112_eb509994-6ecc-4599-b87a-98495fef6129.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0254-0460-01 00254046001 100 CAPSULE in 1 BOTTLE (0254-0460-01) 100 capsule 2023-11-01 No No Current