colchicine

Product NDC: 63629-8362
11-digit product format: 636298362
Labeler code: 63629
Product ID: 63629-8362_3f922884-7115-4509-b5f9-1e93563be69f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colchicine
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA211250
Marketing category: ANDA
Marketing start: 2019-02-10
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211250-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211250-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211250-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211250-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211250-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211250-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211250-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211250-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211250-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211250-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211250-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211250-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211250-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211250-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211250-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211250-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211250-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211250-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211250-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211250-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211250-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211250-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211250-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211250-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211250-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211250-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211250-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211250-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211250-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211250-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211250-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211250-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211250-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211250-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211250-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211250-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211250-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211250-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211250-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211250-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211250-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211250-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5ae87893-a065-468e-b8da-f1db86afcaef	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51989a2b-944a-b31f-835e-469c133570ad	Product name	2	20250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2	Product name	2	20250214
14efe2b0-2695-4943-8b2f-24f519c99fed	Product name	1	20231023
bf4e8ffd-8f13-3050-5248-581676b7ea42	Product name	6	20221214
987af351-b977-4822-ac44-c76d29e24e78	Product name	1	20190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-8362-1	colchicine	30 in 1 BOTTLE	TABLET	30	106
63629-8362-2	colchicine	20 in 1 BOTTLE	TABLET	20	106
63629-8362-3	colchicine	3 in 1 BOTTLE	TABLET	3	106
63629-8362-4	colchicine	12 in 1 BOTTLE	TABLET	12	106
63629-8362-5	colchicine	6 in 1 BOTTLE	TABLET	6	106
63629-8362-6	colchicine	9 in 1 BOTTLE	TABLET	9	106
63629-8362-7	colchicine	15 in 1 BOTTLE	TABLET	15	106
63629-8362-8	colchicine	10 in 1 BOTTLE	TABLET	10	106
63629-8362-9	colchicine	90 in 1 BOTTLE	TABLET	90	106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8362	COLCHICINE TABLET [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 9 package rows	20231108_5ae87893-a065-468e-b8da-f1db86afcaef.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
colchicine	COLCHICINE	A-S Medication Solutions	5c1ceff7-8f00-48cc-8ea4-678106455ff1	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Bryant Ranch Prepack	5ae87893-a065-468e-b8da-f1db86afcaef	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250 ndc (product): 63629-8362
colchicine	COLCHICINE	Ascend Laboratories, LLC	a4284783-fea6-4af2-9a8d-79c929176c05	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	ST. MARY'S MEDICAL PARK PHARMACY	5102af58-15b1-1516-e063-6294a90a50e3	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Bryant Ranch Prepack	8b78d6f7-714b-4e6c-b109-fbcb96d66633	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	NuCare Pharmaceuticals,Inc.	d010a735-1a20-23fe-e053-2995a90abe0f	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Bryant Ranch Prepack	11a62c34-db88-4a79-81a1-59b316d41d66	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SML2Y3J35T	COLCHICINE	64-86-8	COLCHICINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197541	colchicine 0.6 MG Oral Tablet	PSN	5ae87893-a065-468e-b8da-f1db86afcaef	106
197541	colchicine 0.6 MG Oral Tablet	SCD	5ae87893-a065-468e-b8da-f1db86afcaef	106
197541	colchicine 600 MCG Oral Tablet	SY	5ae87893-a065-468e-b8da-f1db86afcaef	106

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8362-1	63629836201	30 TABLET in 1 BOTTLE (63629-8362-1)	30 tablet	2020-11-16	0000-00-00	No	No	Current
63629-8362-2	63629836202	20 TABLET in 1 BOTTLE (63629-8362-2)	20 tablet	2022-09-01	0000-00-00	No	No	Current
63629-8362-3	63629836203	3 TABLET in 1 BOTTLE (63629-8362-3)	3 tablet	2022-09-01	0000-00-00	No	No	Current
63629-8362-4	63629836204	12 TABLET in 1 BOTTLE (63629-8362-4)	12 tablet	2022-09-01	0000-00-00	No	No	Current
63629-8362-5	63629836205	6 TABLET in 1 BOTTLE (63629-8362-5)	6 tablet	2022-09-01	0000-00-00	No	No	Current
63629-8362-6	63629836206	9 TABLET in 1 BOTTLE (63629-8362-6)	9 tablet	2022-09-01	0000-00-00	No	No	Current
63629-8362-7	63629836207	15 TABLET in 1 BOTTLE (63629-8362-7)	15 tablet	2022-09-01	0000-00-00	No	No	Current
63629-8362-8	63629836208	10 TABLET in 1 BOTTLE (63629-8362-8)	10 tablet	2022-09-01	0000-00-00	No	No	Current
63629-8362-9	63629836209	90 TABLET in 1 BOTTLE (63629-8362-9)	90 tablet	2022-09-01		No	No	Current