FDA.reportPublic FDA data

INDOMETHACIN

Product NDC
42254-237
11-digit product format
422540237
Labeler code
42254
Product ID
42254-237_4b8dbfb7-5f20-4398-937a-72ed536c57c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA018851
Marketing category
ANDA
Marketing start
2010-07-30
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
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
42254-237-152019-09-24C16284748780-19350213a-3bf9-c013-e053-90daa90a1393Indomethacin Capsules, USP Rx Only
42254-237-302019-09-24C16284748780-19350213a-3bf9-c013-e053-90daa90a1393Indomethacin Capsules, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-237-15INDOMETHACIN15 in 1 BOTTLE, PLASTICCAPSULE151
42254-237-30INDOMETHACIN30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-237-15EA - Each42254-23771123d2d-737e-44b0-901b-8f4f901fffe212013-03-03
42254-237-30EA - Each42254-237603578be-b327-4aad-b8f6-9f9bb94ff9f712013-03-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-237INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130221_4b8dbfb7-5f20-4398-937a-72ed536c57c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN4b8dbfb7-5f20-4398-937a-72ed536c57c41
197817indomethacin 25 MG Oral CapsuleSCD4b8dbfb7-5f20-4398-937a-72ed536c57c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-237-154225402371515 in 1 BOTTLE, PLASTICHistorical
42254-237-304225402373030 in 1 BOTTLE, PLASTICHistorical