colchicine

Product NDC
71205-687
11-digit product format
712050687
Labeler code
71205
Product ID
71205-687_62a7d89d-9856-446f-aaa2-962825fef0a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209876
Marketing category
ANDA
Marketing start
2020-06-11
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209876-001COLCHICINECOLCHICINE0.6MGTABLET / ORALAB2019-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209876-001AB

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 UTC2026-02A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-063f01610625f2…
2019-09-15 20:21 UTC2019-09A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209876-001COLCHICINE0.6MGTABLET / ORALAB2019-09-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209876-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209876-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209876-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209876-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209876-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209876-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209876-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209876-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209876-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209876-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209876-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209876-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209876-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209876-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209876-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209876-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209876-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209876-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209876-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209876-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209876-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209876-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209876-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209876-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209876-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209876-001AB1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209876-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209876-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209876-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209876-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209876-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209876-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209876-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209876-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209876-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209876-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209876-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209876-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209876-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209876-001AB1a50c72e98297…

Additional Listing Data#

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

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
0f69b9c6-8c00-45e2-b950-34dc5ae62352Available 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
71205-687-05colchicine5 in 1 BOTTLETABLET54
71205-687-10colchicine10 in 1 BOTTLETABLET104
71205-687-21colchicine21 in 1 BOTTLETABLET214
71205-687-30colchicine30 in 1 BOTTLETABLET304
71205-687-60colchicine60 in 1 BOTTLETABLET604
71205-687-90colchicine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-687-05EA - Each71205-6878b79ced8-6cc5-4e0c-b260-10c5ac4d61f312026-02-05
71205-687-10EA - Each71205-687794be6f4-b979-467a-b777-023859f8938512022-12-07
71205-687-21EA - Each71205-6870222bd4c-2957-4e9a-86fe-964d953ec4a312025-06-13
71205-687-30EA - Each71205-687447f16bc-9d1a-48a6-969b-ba4be68fb46812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-687COLCHICINE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20250501_0f69b9c6-8c00-45e2-b950-34dc5ae62352.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.b414be4e-cd4f-4e7d-bbdd-b406c99c11b62026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209876
application number: ANDA209876
colchicineCOLCHICINEDr.Reddys Laboratories, Inc.2cd5298e-43c6-a8dc-4467-9a3e1ade93072025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209876
application number: ANDA209876
colchicineCOLCHICINEProficient Rx LP0f69b9c6-8c00-45e2-b950-34dc5ae623522025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209876
application number: ANDA209876
ndc (product): 71205-687
COLCHICINECOLCHICINEDirect Rxd92b7189-78fd-693d-e053-2a95a90a7c732025-01-21Exact identifier
application applno (ANDA): 209876
application number: ANDA209876
colchicineCOLCHICINEBryant Ranch Prepack14d4be16-d355-4baf-b4cd-4d97d4b2dca02023-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209876
application number: ANDA209876

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN0f69b9c6-8c00-45e2-b950-34dc5ae623524
197541colchicine 0.6 MG Oral TabletSCD0f69b9c6-8c00-45e2-b950-34dc5ae623524
197541colchicine 600 MCG Oral TabletSY0f69b9c6-8c00-45e2-b950-34dc5ae623524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-687-05712050687055 TABLET in 1 BOTTLE (71205-687-05) 5 tablet2025-07-17NoNoCurrent
71205-687-107120506871010 TABLET in 1 BOTTLE (71205-687-10) 10 tablet2022-10-270000-00-00NoNoCurrent
71205-687-217120506872121 TABLET in 1 BOTTLE (71205-687-21) 21 tablet2025-04-25NoNoCurrent
71205-687-307120506873030 TABLET in 1 BOTTLE (71205-687-30) 30 tablet2022-08-220000-00-00NoNoCurrent
71205-687-607120506876060 TABLET in 1 BOTTLE (71205-687-60) 60 tablet2022-08-220000-00-00NoNoCurrent
71205-687-907120506879090 TABLET in 1 BOTTLE (71205-687-90) 90 tablet2022-08-220000-00-00NoNoCurrent