Indomethacin

Product NDC
42254-081
11-digit product format
422540081
Labeler code
42254
Product ID
42254-081_4f5f9977-2a78-4bf1-8e14-20dd24a119b4
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-081-15Indomethacin15 in 1 BOTTLECAPSULE153
42254-081-21Indomethacin21 in 1 BOTTLECAPSULE213
42254-081-30Indomethacin30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-081-15EA - Each42254-081822c91e1-6d5e-4ae8-9921-f2a8e20b245612013-03-03
42254-081-21EA - Each42254-081ef5a3ff6-ff62-4377-b1d6-be0edbfe2d5412012-07-24
42254-081-30EA - Each42254-08139c5a86e-f108-4a15-ac5e-74e4427e7e9d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
WATERINACTIVE INGREDIENT059QF0KO0RINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-081INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3Legacy NDC, 3 package rows20130221_9f082d89-d218-49e0-8fcb-0000b5eb04a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN9f082d89-d218-49e0-8fcb-0000b5eb04a53
197818indomethacin 50 MG Oral CapsuleSCD9f082d89-d218-49e0-8fcb-0000b5eb04a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-081-154225400811515 in 1 BOTTLEHistorical
42254-081-214225400812121 in 1 BOTTLEHistorical
42254-081-304225400813030 in 1 BOTTLEHistorical