FDA.reportPublic FDA data

INDOMETHACIN

Product NDC
55289-469
11-digit product format
552890469
Labeler code
55289
Product ID
55289-469_34679342-bf84-f9e4-e063-6294a90aae55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA079175
Marketing category
ANDA
Marketing start
2009-03-06
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
55289-469-10INDOMETHACIN10 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-469-10EA - Each55289-4699f9c26f3-55e5-4116-9778-467a626dc96712015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AINDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-469INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 1 package rows20250507_85014b51-1354-4d16-9995-3ee33a7155fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN85014b51-1354-4d16-9995-3ee33a7155fa13
310992indomethacin 75 MG Extended Release Oral CapsuleSCD85014b51-1354-4d16-9995-3ee33a7155fa13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-469-105528904691010 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-469-10) 2012-07-270000-00-00NoNoCurrent