Home NDC 67046-1634 COLCHICINE
Product NDC 67046-1634
11-digit product format 670461634
Labeler code 67046
Product ID 67046-1634_486f5e01-4fc0-6f5c-e063-6394a90a19f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLCHICINE
Dosage form CAPSULE
Route ORAL
Labeler Coupler LLC
Application ANDA217620
Marketing category ANDA
Marketing start 2025-12-30
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 A217620-001 COLCHICINE COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217620-001 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 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217620-001 COLCHICINE 0.6MG CAPSULE / ORAL AB 2024-04-29 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 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 67046-1634-3 COLCHICINE 30 in 1 BLISTER PACK CAPSULE 30 3
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 · 2 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 67046-1634-3 67046163403 30 CAPSULE in 1 BLISTER PACK (67046-1634-3) 30 capsule 2025-12-30 No No Current