Home NDC 31722-099 COLCHICINE
Product NDC 31722-099
11-digit product format 317220099
Labeler code 31722
Product ID 31722-099_1d9751e6-7a6c-6828-e063-6394a90a7783
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLCHICINE
Dosage form CAPSULE
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA217620
Marketing category ANDA
Marketing start 2024-04-29
Substance COLCHICINE
Active strength .6 mg/1
Pharmacologic classes Alkaloid [EPC], Alkaloids [CS]
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 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 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 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 31722-099-01 COLCHICINE 100 in 1 BOTTLE CAPSULE 100 1 31722-099-10 COLCHICINE 1000 in 1 BOTTLE CAPSULE 1000 1 31722-099-30 COLCHICINE 30 in 1 BOTTLE CAPSULE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-099 COLCHICINE (COLCHICINE) CAPSULE [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 3 package rows 20240720_b280f0dc-b24c-4606-aaf4-0673070d5b64.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 · 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 31722-099-01 31722009901 100 CAPSULE in 1 BOTTLE (31722-099-01) 100 capsule 2024-04-29 No No Current 31722-099-10 31722009910 1000 CAPSULE in 1 BOTTLE (31722-099-10) 1000 capsule 2024-04-29 No No Current 31722-099-30 31722009930 30 CAPSULE in 1 BOTTLE (31722-099-30) 30 capsule 2024-04-29 No No Current