INDOMETHACIN

Product NDC
61919-487
11-digit product format
619190487
Labeler code
61919
Product ID
61919-487_8f04029c-263e-4334-b501-76525d049a31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRX
Application
NDA018851
Marketing category
NDA
Marketing start
2015-01-01
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
61919-487-302020-01-31C16284748780-19d75b9d0-a7ef-f424-e053-dadaa90a57ceINDOMETHACIN
61919-487-602020-01-31C16284748780-19d75b9d0-a7ef-f424-e053-dadaa90a57ceINDOMETHACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-487-30INDOMETHACIN30 in 1 BOTTLECAPSULE301
61919-487-60INDOMETHACIN60 in 1 BOTTLECAPSULE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [DIRECTRX]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [DIRECTRX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHINDOMETHACIN CAPSULE [DIRECTRX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [DIRECTRX]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYINDOMETHACIN CAPSULE [DIRECTRX]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [DIRECTRX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-487INDOMETHACIN CAPSULE [DIRECTRX]1Legacy NDC, 2 package rows20151022_74099022-892a-46d8-a64e-4a9d7d3256cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN74099022-892a-46d8-a64e-4a9d7d3256cd1
197818indomethacin 50 MG Oral CapsuleSCD74099022-892a-46d8-a64e-4a9d7d3256cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-487-306191904873030 in 1 BOTTLEHistorical
61919-487-606191904876060 in 1 BOTTLEHistorical