Home NDC 33342-341 Colchicine
Product NDC 33342-341
11-digit product format 333420341
Labeler code 33342
Product ID 33342-341_9111bbad-b020-44fb-b276-d7853e5acd2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA210633
Marketing category ANDA
Marketing start 2017-04-24
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 A210633-001 COLCHICINE COLCHICINE 0.6MG TABLET / ORAL AB 2026-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210633-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210633-001 COLCHICINE 0.6MG TABLET / ORAL AB 2026-02-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210633-001 AB 1 a50c72e98297…
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 33342-341-07 Colchicine 30 in 1 BOTTLE TABLET 30 1 33342-341-11 Colchicine 100 in 1 BOTTLE TABLET 100 1 33342-341-15 Colchicine 500 in 1 BOTTLE TABLET 500 1 33342-341-42 Colchicine 10 in 1 BLISTER PACK TABLET 10 1 33342-341-42 Colchicine 11 in 1 CARTON TABLET 11 1
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 33342-341-07 33342034107 30 TABLET in 1 BOTTLE (33342-341-07) 30 tablet 2018-08-23 No No Current 33342-341-11 33342034111 100 TABLET in 1 BOTTLE (33342-341-11) 100 tablet 2018-08-23 No No Current 33342-341-15 33342034115 500 TABLET in 1 BOTTLE (33342-341-15) 500 tablet 2018-08-23 No No Current 33342-341-42 33342034142 11 BLISTER PACK in 1 CARTON (33342-341-42) / 10 TABLET in 1 BLISTER PACK 11 blister pack 2018-08-23 No No Current