Colcrys

Product NDC: 64764-119
11-digit product format: 647640119
Labeler code: 64764
Product ID: 64764-119_93732d0e-7f4c-45d0-a522-76962b79434f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022352
Marketing category: NDA
Marketing start: 2009-09-01
Marketing end: 0000-00-00
Substance: COLCHICINE
Active strength: 1 mg/1
Pharmacologic classes: Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-119-01	EA - Each	64764-119	52719dce-a115-4b80-bc47-74390c474842	1	2013-02-13
64764-119-07	EA - Each	64764-119	904dcc80-dd95-41f9-b226-965b46d41a86	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64764-119	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	14	Legacy NDC	20231230_56c130d1-7581-4152-99a2-0014ee9366c0.zip

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	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	Colcrys 0.6 MG Oral Tablet	PSN	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	colchicine 0.6 MG Oral Tablet [Colcrys]	SBD	d6adc880-5499-4691-93f3-27c87902d5fc	4
197541	colchicine 0.6 MG Oral Tablet	SCD	d6adc880-5499-4691-93f3-27c87902d5fc	4
197541	colchicine 600 MCG Oral Tablet	SY	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	Colcrys (colchicine 0.6 MG) Oral Tablet	SY	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	Colcrys 0.6 MG Oral Tablet	SY	d6adc880-5499-4691-93f3-27c87902d5fc	4
197541	colchicine 0.6 MG Oral Tablet	PSN	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	Colcrys 0.6 MG Oral Tablet	PSN	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	colchicine 0.6 MG Oral Tablet [Colcrys]	SBD	a80036fe-3016-4541-aa42-6c06cf37ae55	2
197541	colchicine 0.6 MG Oral Tablet	SCD	a80036fe-3016-4541-aa42-6c06cf37ae55	2
197541	colchicine 600 MCG Oral Tablet	SY	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	Colcrys (colchicine 0.6 MG) Oral Tablet	SY	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	Colcrys 0.6 MG Oral Tablet	SY	a80036fe-3016-4541-aa42-6c06cf37ae55	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-119-01	64764011901	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-01)	2009-09-01	0000-00-00	No	No	Current
64764-119-06	64764011906	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06)	2009-09-01	0000-00-00	No	No	Current
64764-119-07	64764011907	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-07)	2009-09-01	0000-00-00	No	No	Current
64764-119-10	64764011910	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-10)	2009-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colcrys	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Colcrys	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	2

Colcrys

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#