FDA.reportPublic FDA data

INDOMETHACIN ER

Product NDC
12634-160
11-digit product format
126340160
Labeler code
12634
Product ID
12634-160_543aa8e5-219e-41d8-8ffa-9ae1446d3391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca, Inc.
Application
ANDA079175
Marketing category
ANDA
Marketing start
2010-03-04
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
2018-12-31
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
12634-160-002020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-252020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-542020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-552020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-572020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-592020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-602020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-712020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-792020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-802020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-842020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-852020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-912020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP
12634-160-972020-01-31C16284748780-19d75b9d0-87cd-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-160-00INDOMETHACIN ER10 in 1 BOTTLE, PLASTICCAPSULE102
12634-160-25INDOMETHACIN ER25 in 1 BLISTER PACKCAPSULE252
12634-160-54INDOMETHACIN ER14 in 1 BLISTER PACKCAPSULE142
12634-160-55INDOMETHACIN ER15 in 1 BLISTER PACKCAPSULE152
12634-160-57INDOMETHACIN ER20 in 1 BLISTER PACKCAPSULE202
12634-160-59INDOMETHACIN ER30 in 1 BLISTER PACKCAPSULE302
12634-160-60INDOMETHACIN ER60 in 1 BOTTLE, PLASTICCAPSULE602
12634-160-71INDOMETHACIN ER30 in 1 BOTTLE, PLASTICCAPSULE302
12634-160-79INDOMETHACIN ER25 in 1 BOTTLE, PLASTICCAPSULE252
12634-160-80INDOMETHACIN ER20 in 1 BOTTLE, PLASTICCAPSULE202
12634-160-84INDOMETHACIN ER14 in 1 BOTTLE, PLASTICCAPSULE142
12634-160-85INDOMETHACIN ER15 in 1 BOTTLE, PLASTICCAPSULE152
12634-160-91INDOMETHACIN ER1 in 1 BLISTER PACKCAPSULE12
12634-160-97INDOMETHACIN ER7 in 1 BOTTLE, PLASTICCAPSULE72

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-160INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2Legacy NDC, 14 package rows20100419_6569dfd1-0164-4241-b508-ccd540d1e858.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN6569dfd1-0164-4241-b508-ccd540d1e8582
310992indomethacin 75 MG Extended Release Oral CapsuleSCD6569dfd1-0164-4241-b508-ccd540d1e8582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-160-001263401600010 in 1 BOTTLE, PLASTICHistorical
12634-160-251263401602525 in 1 BLISTER PACKHistorical
12634-160-541263401605414 in 1 BLISTER PACKHistorical
12634-160-551263401605515 in 1 BLISTER PACKHistorical
12634-160-571263401605720 in 1 BLISTER PACKHistorical
12634-160-591263401605930 in 1 BLISTER PACKHistorical
12634-160-601263401606060 in 1 BOTTLE, PLASTICHistorical
12634-160-711263401607130 in 1 BOTTLE, PLASTICHistorical
12634-160-791263401607925 in 1 BOTTLE, PLASTICHistorical
12634-160-801263401608020 in 1 BOTTLE, PLASTICHistorical
12634-160-841263401608414 in 1 BOTTLE, PLASTICHistorical
12634-160-851263401608515 in 1 BOTTLE, PLASTICHistorical
12634-160-91126340160911 in 1 BLISTER PACKHistorical
12634-160-97126340160977 in 1 BOTTLE, PLASTICHistorical