FDA.reportPublic FDA data

Indomethacin

Product NDC
50268-431
11-digit product format
502680431
Labeler code
50268
Product ID
50268-431_2e099c64-82cd-0174-e063-6394a90a5207
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA091240
Marketing category
ANDA
Marketing start
2015-05-20
Substance
INDOMETHACIN
Active strength
50 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
INDOMETHACIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui197817, 197818

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
50268-431-11Indomethacin1 in 1 BLISTER PACKCAPSULE17
50268-431-15Indomethacin50 in 1 BOX, UNIT-DOSECAPSULE507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-431-11EA - Each50268-431342209d9-b395-4a3c-bdfd-95f66faa307b12015-06-09
50268-431-15EA - Each50268-4313c3f7a2a-49bb-4eeb-a674-78b27123d42912015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [AVPAK]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [AVPAK]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [AVPAK]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [AVPAK]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [AVPAK]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [AVPAK]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [AVPAK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [AVPAK]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [AVPAK]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-431INDOMETHACIN CAPSULE [AVPAK]7Current NDC, Legacy NDC, 2 package rows20250227_bcaa0e51-a2fc-cf74-027a-1964e38c5e4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSNbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7
197818indomethacin 50 MG Oral CapsulePSNbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7
197817indomethacin 25 MG Oral CapsuleSCDbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7
197818indomethacin 50 MG Oral CapsuleSCDbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-431-11502680431111 in 1 BLISTER PACKHistorical
50268-431-155026804311550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-431-15) / 1 CAPSULE in 1 BLISTER PACK (50268-431-11) 50 blister pack2015-05-200000-00-00NoNoCurrent