Indomethacin

Product NDC
66336-687
11-digit product format
663360687
Labeler code
66336
Product ID
66336-687_8af5d40d-42f1-4201-9ec6-bd96efcd6e3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA091549
Marketing category
ANDA
Marketing start
2010-12-06
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
75 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
66336-687-302019-10-29C16284748780-1960f7f55-d946-8e05-e053-dbdaa90a074aIndomethacin Extended – Release Capsules, USP 75 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-687-30Indomethacin30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-687INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20110930_29a6b41c-accb-4b12-92d1-cda19c2148a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN29a6b41c-accb-4b12-92d1-cda19c2148a51
310992indomethacin 75 MG Extended Release Oral CapsuleSCD29a6b41c-accb-4b12-92d1-cda19c2148a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-687-306633606873030 in 1 BOTTLEHistorical