Colchicine

Product NDC
50090-7205
11-digit product format
500907205
Labeler code
50090
Product ID
50090-7205_6fa1e18b-babc-4a4b-af7c-144980645666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211519
Marketing category
ANDA
Marketing start
2020-11-10
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211519-001COLCHICINECOLCHICINE0.6MGTABLET / ORALAB2019-02-19
A211519-002COLCHICINECOLCHICINE0.3MGTABLET / ORAL2019-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A211519-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211519-001COLCHICINE0.6MGTABLET / ORAL2019-02-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A211519-002COLCHICINE0.3MGTABLET / ORAL2019-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211519-001COLCHICINE0.6MGTABLET / ORALAB2019-02-1987673890dc5c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211519-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211519-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211519-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211519-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211519-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211519-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211519-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211519-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211519-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211519-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211519-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211519-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211519-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211519-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211519-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211519-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211519-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211519-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211519-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211519-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211519-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211519-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211519-001AB1c0c555d07b60…
2019-07-19 19:46 UTC2019-07A211519-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211519-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211519-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211519-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211519-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211519-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211519-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211519-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211519-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211519-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211519-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211519-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211519-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211519-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211519-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Colchicine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICEINE.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HJ30158L57Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b6abc78-b2d6-4949-b109-4c857f37ef12Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51989a2b-944a-b31f-835e-469c133570adProduct name220250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2Product name220250214
14efe2b0-2695-4943-8b2f-24f519c99fedProduct name120231023
bf4e8ffd-8f13-3050-5248-581676b7ea42Product name620221214
987af351-b977-4822-ac44-c76d29e24e78Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7205-7Colchicine4 in 1 BOTTLETABLET41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7205-7EA - Each50090-720589bf1ccf-50a1-4a8c-880e-8c634999ac6b12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7205COLCHICINE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240806_7b6abc78-b2d6-4949-b109-4c857f37ef12.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColchicineCOLCHICINEZydus Lifesciences Limitedcd720ef0-1cb8-40bc-a657-10accb6542b62024-11-26Exact identifier
application applno (ANDA): 211519
application number: ANDA211519
ColchicineCOLCHICINEA-S Medication Solutions7b6abc78-b2d6-4949-b109-4c857f37ef122024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211519
application number: ANDA211519
ndc (product): 50090-7205
ColchicineCOLCHICINENorthstar Rx LLC.94bee24f-d846-4344-bc42-b2eae6b433ba2022-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211519
application number: ANDA211519
ColchicineCOLCHICINEZydus Pharmaceuticals USA Inc.c8fd7034-5ca2-4a58-b303-7f78ffdf8d762022-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211519
application number: ANDA211519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7205-7500907205074 TABLET in 1 BOTTLE (50090-7205-7) 4 tablet2024-08-01NoNoCurrent