Home NDC 70010-002 Colchicine
Product NDC 70010-002
11-digit product format 700100002
Labeler code 70010
Product ID 70010-002_018d4e2e-c594-17cf-e063-6294a90a7bb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Granules Pharmaceuticals Inc.
Application ANDA210425
Marketing category ANDA
Marketing start 2020-05-13
Substance COLCHICINE
Active strength .6 mg/1
Pharmacologic classes Alkaloid [EPC], Alkaloids [CS], 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 70010-002-01 Colchicine 100 in 1 BOTTLE TABLET, FILM COATED 100 12 70010-002-03 Colchicine 30 in 1 BOTTLE TABLET, FILM COATED 30 12 70010-002-10 Colchicine 1000 in 1 BOTTLE TABLET, FILM COATED 1000 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70010-002 COLCHICINE TABLET, FILM COATED [GRANULES PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 3 package rows 20230729_dcf97364-b35f-4bc9-8a92-d3d2e05f47ac.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 70010-002-01 70010000201 100 TABLET, FILM COATED in 1 BOTTLE (70010-002-01) 2020-05-13 0000-00-00 No No Current 70010-002-03 70010000203 30 TABLET, FILM COATED in 1 BOTTLE (70010-002-03) 2020-05-13 0000-00-00 No No Current 70010-002-10 70010000210 1000 TABLET, FILM COATED in 1 BOTTLE (70010-002-10) 2023-05-13 No No Current