Indomethacin

Product NDC
21695-522
11-digit product format
216950522
Labeler code
21695
Product ID
21695-522_622ac159-4d19-4c4a-95e2-c3757abf5102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
25 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-522-21Indomethacin21 in 1 BOTTLECAPSULE212
21695-522-30Indomethacin30 in 1 BOTTLECAPSULE302
21695-522-60Indomethacin60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-522-21EA - Each21695-52235f96ff0-df8a-45c4-b1f7-2eb174a5848312012-07-24
21695-522-30EA - Each21695-5224f1f0eae-dd18-4294-aa8f-6a3743a91a1612012-07-24
21695-522-60EA - Each21695-52206811f5e-ef93-47e6-a598-d18ff6f4621212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-522INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 3 package rows20111021_1f60d27b-fa95-40dd-969f-51f977142032.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN1f60d27b-fa95-40dd-969f-51f9771420322
197817indomethacin 25 MG Oral CapsuleSCD1f60d27b-fa95-40dd-969f-51f9771420322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-522-212169505222121 in 1 BOTTLEHistorical
21695-522-302169505223030 in 1 BOTTLEHistorical
21695-522-602169505226060 in 1 BOTTLEHistorical