Indomethacin extended-release

Product NDC
68387-345
11-digit product format
683870345
Labeler code
68387
Product ID
68387-345_7e1f7076-7c07-4f46-ba25-9dd18aa47baa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin extended-release
Dosage form
CAPSULE
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA074464
Marketing category
ANDA
Marketing start
2006-01-09
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
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
68387-345-302019-10-21C16284748780-1956f9ecf-cc51-621f-e053-dbdaa90a74adIndomethacin Extended-Release Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-345-30Indomethacin extended-release30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-345-30EA - Each68387-345900e9053-38a6-4c0b-bd82-be9b72dcdc1d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-345INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2Legacy NDC, 1 package rows20100908_3125cb9f-d00c-47e7-9927-fbe38cadb48b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN3125cb9f-d00c-47e7-9927-fbe38cadb48b2
310992indomethacin 75 MG Extended Release Oral CapsuleSCD3125cb9f-d00c-47e7-9927-fbe38cadb48b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-345-306838703453030 in 1 BOTTLE, PLASTICHistorical