Colchicine

Product NDC
0143-3018
11-digit product format
001433018
Labeler code
0143
Product ID
0143-3018_76a875b0-99ff-4f9a-9113-ad5e122b7a79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA204820
Marketing category
NDA
Marketing start
2014-10-01
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

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 Identifiers#

Field, Values table
FieldValues
UniiSML2Y3J35T
Rxcui1550940

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
0143-3018-01Colchicine100 in 1 BOTTLE, PLASTICCAPSULE10022
0143-3018-10Colchicine1000 in 1 BOTTLE, PLASTICCAPSULE100022
0143-3018-30Colchicine30 in 1 BOTTLE, PLASTICCAPSULE3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-3018-01EA - Each0143-3018474b9312-f0c0-44dd-9163-30e736c7808512015-02-02
0143-3018-10EA - Each0143-3018c96a9166-e18d-4024-afed-3cf9b8a3611612015-02-02
0143-3018-30EA - Each0143-3018d27add5b-f20c-4d5a-8520-23781e84c9d512018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLCHICINEACTIVE INGREDIENTSML2Y3J35TCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
COLCHICINEACTIVE MOIETYSML2Y3J35TCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
GELATININACTIVE INGREDIENT2G86QN327LCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11
WATERINACTIVE INGREDIENT059QF0KO0RCOLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-3018COLCHICINE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]21Current NDC, Legacy NDC, 3 package rows20240524_ee1583ac-c308-4beb-b602-9ecac4977026.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550940colchicine 0.6 MG Oral CapsulePSNee1583ac-c308-4beb-b602-9ecac497702622
1550940colchicine 0.6 MG Oral CapsuleSCDee1583ac-c308-4beb-b602-9ecac497702622
1550940colchicine 0.6 MG Oral CapsulePSN25307250-c16b-4467-9ad0-e6c752c576bd14
1550940colchicine 0.6 MG Oral CapsuleSCD25307250-c16b-4467-9ad0-e6c752c576bd14
1550940colchicine 0.6 MG Oral CapsulePSN2f5e24de-3956-4724-a5d7-fe81dcb07f6e7
1550940colchicine 0.6 MG Oral CapsuleSCD2f5e24de-3956-4724-a5d7-fe81dcb07f6e7
1550940colchicine 0.6 MG Oral CapsulePSN19486f52-1c7b-43b8-ba48-0d1a6389fedf5
1550940colchicine 0.6 MG Oral CapsuleSCD19486f52-1c7b-43b8-ba48-0d1a6389fedf5
1550940colchicine 0.6 MG Oral CapsulePSN2cb88c93-54b8-a548-e063-6294a90a94e62
1550940colchicine 0.6 MG Oral CapsuleSCD2cb88c93-54b8-a548-e063-6294a90a94e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-3018-0100143301801100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01) 100 capsule2014-10-010000-00-00NoNoCurrent
0143-3018-10001433018101000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10) 1000 capsule2014-10-010000-00-00NoNoCurrent
0143-3018-300014330183030 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-30) 30 capsule2018-07-230000-00-00NoNoCurrent