COLCHICINE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:17

Label at a glance#

ProductColchicine

Active ingredientCOLCHICEINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1396-3

Colchicine tablets, USP 0.6 mg

30 Tablets

Rx only

NDC 70771-1590-3

Colchicine tablets, USP 0.3 mg

30 Tablets

Rx only

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
70771-1396-1	Colchicine	100 in 1 BOTTLE	TABLET	100	5
70771-1396-1	Colchicine	1 in 1 CARTON	TABLET	1	5
70771-1396-3	Colchicine	1 in 1 CARTON	TABLET	1	5
70771-1396-3	Colchicine	30 in 1 BOTTLE	TABLET	30	5
70771-1396-5	Colchicine	1 in 1 CARTON	TABLET	1	5
70771-1396-5	Colchicine	500 in 1 BOTTLE	TABLET	500	5
70771-1396-9	Colchicine	90 in 1 BOTTLE	TABLET	90	5
70771-1396-9	Colchicine	1 in 1 CARTON	TABLET	1	5
70771-1590-1	Colchicine	1 in 1 CARTON	TABLET	1	5
70771-1590-1	Colchicine	100 in 1 BOTTLE	TABLET	100	5
70771-1590-3	Colchicine	1 in 1 CARTON	TABLET	1	5
70771-1590-3	Colchicine	30 in 1 BOTTLE	TABLET	30	5
70771-1590-5	Colchicine	500 in 1 BOTTLE	TABLET	500	5
70771-1590-5	Colchicine	1 in 1 CARTON	TABLET	1	5
70771-1590-9	Colchicine	90 in 1 BOTTLE	TABLET	90	5
70771-1590-9	Colchicine	1 in 1 CARTON	TABLET	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1396	COLCHICINE TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 8 package rows	20241128_cd720ef0-1cb8-40bc-a657-10accb6542b6.zip
70771-1590	COLCHICINE TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 8 package rows	20241128_cd720ef0-1cb8-40bc-a657-10accb6542b6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

Colchicine
COLCHICEINE
CARMINIC ACID
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1396	70771-1396-3, 70771-1396-9, 70771-1396-1, 70771-1396-5
70771-1590	70771-1590-3, 70771-1590-9, 70771-1590-1, 70771-1590-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COLCHICEINE	HJ30158L57	ACTIM
CARMINIC ACID	CID8Z8N95N	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
COLCHICEINE	HJ30158L57	ACTIM
CARMINIC ACID	CID8Z8N95N	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 3 · 84 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
2026-10-15 13:18:30	2026-09	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`caaa826d4ba7…`
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…`

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
2026-10-15 13:18:30	2026-09	A211519-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211519-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211519-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211519-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211519-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211519-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211519-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211519-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211519-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211519-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211519-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211519-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211519-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211519-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211519-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211519-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211519-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211519-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211519-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211519-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211519-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211519-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211519-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211519-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211519-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211519-001	AB	1	`c0c555d07b60…`
2019-07-19 19:46 UTC	2019-07	A211519-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211519-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211519-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211519-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211519-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211519-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211519-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211519-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211519-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211519-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211519-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211519-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211519-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211519-001	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Zydus Lifesciences Limited	cd720ef0-1cb8-40bc-a657-10accb6542b6	2024-11-26		Exact identifier ndc (package): 70771-1590-9 ndc (package): 70771-1396-1 ndc (package): 70771-1396-9 ndc (package): 70771-1590-3 ndc (package): 70771-1590-5 ndc (package): 70771-1396-5 ndc (package): 70771-1396-3 ndc (package): 70771-1590-1 ndc (product): 70771-1396 ndc (product): 70771-1590 ndc11 (package): 70771159005 ndc11 (package): 70771159009 ndc11 (package): 70771139601 ndc11 (package): 70771159001 ndc11 (package): 70771139605 ndc11 (package): 70771139603 ndc11 (package): 70771159003 ndc11 (package): 70771139609 spl id: 9bfd545b-8ea3-4758-b6dc-fff2e9af14ee spl set id: cd720ef0-1cb8-40bc-a657-10accb6542b6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.