FDA.reportPublic FDA data

Indomethacin

Product NDC
0185-0720
11-digit product format
001850720
Labeler code
0185
Product ID
0185-0720_2fe1b020-0d07-4a5b-9792-05af56e72c31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA074464
Marketing category
ANDA
Marketing start
1998-05-28
Marketing end
2020-04-30
Substance
INDOMETHACIN
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0720-01EA - Each0185-07202df8db3e-5530-4363-8ce2-aeba745c513a12012-07-24
0185-0720-05EA - Each0185-07206b75f63b-a185-4027-ab84-34f528b89ce512012-07-24
0185-0720-60EA - Each0185-07200a8eed60-a850-4116-b679-3e6b29f197d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, 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
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN EXTENDED-RELEASE CAPSULE [KELTMAN PHARMACEUTICALS INC.]2
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

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 CapsulePSN6569dfd1-0164-4241-b508-ccd540d1e8582
310992indomethacin 75 MG Extended Release Oral CapsuleSCD3125cb9f-d00c-47e7-9927-fbe38cadb48b2
310992indomethacin 75 MG Extended Release Oral CapsuleSCD6569dfd1-0164-4241-b508-ccd540d1e8582
310992indomethacin 75 MG Extended Release Oral CapsulePSN5e211b18-8cdc-42ab-8756-4ce2dd94925c1
310992indomethacin 75 MG Extended Release Oral CapsuleSCD5e211b18-8cdc-42ab-8756-4ce2dd94925c1