FDA.reportPublic FDA data

indomethacin

Product NDC
68462-325
11-digit product format
684620325
Labeler code
68462
Product ID
68462-325_e729f88c-b2c8-4462-98be-7184de95b01d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA203501
Marketing category
ANDA
Marketing start
2017-06-22
Substance
INDOMETHACIN
Active strength
75 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
indomethacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDOMETHACIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui310992

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-325-01indomethacin100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10013
68462-325-05indomethacin500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50013
68462-325-10indomethacin1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100013
68462-325-60indomethacin60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6013
68462-325-90indomethacin90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-325-01EA - Each68462-325c398c65c-2e44-46c8-8b5f-dd4d3d01ad4c12017-08-11
68462-325-60EA - Each68462-325e2bd5df7-1ccc-4072-9182-b529f95c1dcc12017-08-11
68462-325-90EA - Each68462-325d5a07646-b456-4a15-ac37-32addbcbef0c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-325INDOMETHACIN CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 5 package rows20240104_532d40b2-c05c-4d4f-b7ee-e6434c4c27fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN532d40b2-c05c-4d4f-b7ee-e6434c4c27fc13
310992indomethacin 75 MG Extended Release Oral CapsuleSCD532d40b2-c05c-4d4f-b7ee-e6434c4c27fc13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-325-0168462032501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01) 2017-06-220000-00-00NoNoCurrent
68462-325-0568462032505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05) 2017-06-220000-00-00NoNoCurrent
68462-325-10684620325101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-10) 2017-06-220000-00-00NoNoCurrent
68462-325-606846203256060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-60) 2017-06-220000-00-00NoNoCurrent
68462-325-906846203259090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-90) 2017-06-220000-00-00NoNoCurrent