Colchicine

Product NDC
51407-082
11-digit product format
514070082
Labeler code
51407
Product ID
51407-082_4f73f4fc-b62d-1b2a-e063-6394a90a1654
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA210425
Marketing category
ANDA
Marketing start
2020-02-05
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210425-001COLCHICINECOLCHICINE0.6MGTABLET / ORALAB2020-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210425-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-054b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210425-001COLCHICINE0.6MGTABLET / ORALAB2020-02-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210425-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210425-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210425-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210425-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210425-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210425-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210425-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210425-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210425-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210425-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210425-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210425-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210425-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210425-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210425-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210425-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210425-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210425-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210425-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210425-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210425-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210425-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210425-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210425-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210425-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210425-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210425-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210425-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210425-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210425-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210425-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210425-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210425-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210425-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210425-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210425-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210425-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Colchicine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICINE.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SML2Y3J35TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197541Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac12e420-9f29-018e-e053-2a95a90ab612Available 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
51407-082-01Colchicine100 in 1 BOTTLETABLET, FILM COATED1007
51407-082-30Colchicine30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-082-01EA - Each51407-0820b1bc0f8-bafc-4112-b048-48ffceab72d812020-09-14
51407-082-30EA - Each51407-08237b7e83c-6721-4eac-a15e-ee6306bdc6ab12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-082COLCHICINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, Legacy NDC, 2 package rows20231101_ac12e420-9f29-018e-e053-2a95a90ab612.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColchicineCOLCHICINEREMEDYREPACK INC.f818ffe0-43df-4cc6-bc86-00b2c79b06fc2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210425
application number: ANDA210425
ColchicineCOLCHICINEGolden State Medical Supply, Inc.ac12e420-9f29-018e-e053-2a95a90ab6122026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210425
application number: ANDA210425
ndc (product): 51407-082
ColchicineCOLCHICINEMajor Pharmaceuticals9e7c8f65-4722-4187-9014-8fa81eb5681e2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210425
application number: ANDA210425
ColchicineCOLCHICINEGranules Pharmaceuticals Inc.dcf97364-b35f-4bc9-8a92-d3d2e05f47ac2023-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210425
application number: ANDA210425
ColchicineCOLCHICINEAphena Pharma Solutions - Tennessee, LLCb310c57c-9192-4dc8-b76f-2c1982941caf2020-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210425
application number: ANDA210425

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNac12e420-9f29-018e-e053-2a95a90ab6127
197541colchicine 0.6 MG Oral TabletSCDac12e420-9f29-018e-e053-2a95a90ab6127
197541colchicine 600 MCG Oral TabletSYac12e420-9f29-018e-e053-2a95a90ab6127
197541colchicine 0.6 MG Oral TabletPSNb310c57c-9192-4dc8-b76f-2c1982941caf1
197541colchicine 0.6 MG Oral TabletSCDb310c57c-9192-4dc8-b76f-2c1982941caf1
197541colchicine 600 MCG Oral TabletSYb310c57c-9192-4dc8-b76f-2c1982941caf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-082-0151407008201100 TABLET, FILM COATED in 1 BOTTLE (51407-082-01) 2020-07-240000-00-00NoNoCurrent
51407-082-305140700823030 TABLET, FILM COATED in 1 BOTTLE (51407-082-30) 2020-07-242027-06-30NoNoCurrent