Indomethacin

Product NDC
66116-529
11-digit product format
661160529
Labeler code
66116
Product ID
66116-529_877417ef-7706-44cf-a8a7-1fec3e7a0266
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA070756
Marketing category
ANDA
Marketing start
2007-12-14
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-529-202019-11-27C16284748780-19855d018-e4d1-cd31-e053-dbdaa90ab51aINDOMETHACIN CAPSULES USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-529-20Indomethacin20 in 1 BOTTLECAPSULE201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [MEDVANTX, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APINDOMETHACIN CAPSULE [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-529INDOMETHACIN CAPSULE [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130820_877417ef-7706-44cf-a8a7-1fec3e7a0266.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN877417ef-7706-44cf-a8a7-1fec3e7a02661
197818indomethacin 50 MG Oral CapsuleSCD877417ef-7706-44cf-a8a7-1fec3e7a02661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-529-206611605292020 in 1 BOTTLEHistorical