Home NDC 70710-1351 Colchicine
Product NDC 70710-1351
11-digit product format 707101351
Labeler code 70710
Product ID 70710-1351_cf874687-3377-4fd3-9616-6c1f74454ad3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA211519
Marketing category ANDA
Marketing start 2019-06-12
Substance COLCHICEINE
Active strength .6 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211519-001 COLCHICINE COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 A211519-002 COLCHICINE COLCHICINE 0.3MG TABLET / ORAL 2019-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211519-001 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 · 78 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 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211519-001 COLCHICINE 0.6MG TABLET / ORAL 2019-02-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211519-002 COLCHICINE 0.3MG TABLET / ORAL 2019-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211519-001 COLCHICINE 0.6MG TABLET / ORAL AB 2019-02-19 87673890dc5c…
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 COLCHICEINE .6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HJ30158L57 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1351 COLCHICINE TABLET [ZYDUS PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 8 package rows 20221011_c8fd7034-5ca2-4a58-b303-7f78ffdf8d76.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 · 4 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70710-1351-1 70710135101 1 BOTTLE in 1 CARTON (70710-1351-1) / 100 TABLET in 1 BOTTLE 1 bottle 2019-06-12 0000-00-00 No No Current 70710-1351-3 70710135103 1 BOTTLE in 1 CARTON (70710-1351-3) / 30 TABLET in 1 BOTTLE 1 bottle 2019-06-12 0000-00-00 No No Current 70710-1351-5 70710135105 1 BOTTLE in 1 CARTON (70710-1351-5) / 500 TABLET in 1 BOTTLE 1 bottle 2019-06-12 0000-00-00 No No Current 70710-1351-9 70710135109 1 BOTTLE in 1 CARTON (70710-1351-9) / 90 TABLET in 1 BOTTLE 1 bottle 2019-06-12 0000-00-00 No No Current