FDA.reportPublic FDA data

INDOMETHACIN

Product NDC
10702-016
11-digit product format
107020016
Labeler code
10702
Product ID
10702-016_30a4fdec-3f89-034c-e063-6294a90aa786
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
KVK-Tech, 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-016-012024-02-19C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-032024-02-19C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-062024-02-19C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-092024-02-19C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-102024-02-19C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-502024-02-19C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-012024-01-30C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-032024-01-30C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-062024-01-30C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-092024-01-30C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-102024-01-30C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965
10702-016-502024-01-30C16284748780-11030e365-2306-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use INDOMETHACIN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN EXTENDED-RELEASE CAPSULES. INDOMETHACIN extended-release capsules for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-016-01INDOMETHACIN100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10015
10702-016-03INDOMETHACIN30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015
10702-016-06INDOMETHACIN60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6015
10702-016-09INDOMETHACIN90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9015
10702-016-10INDOMETHACIN1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100015
10702-016-50INDOMETHACIN500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-016-01EA - Each10702-01640a06004-7e2d-4de8-ba4f-0dc3db03ded012013-02-13
10702-016-03EA - Each10702-016a8937c2c-d893-4b62-a57d-d235a1cc7c2612013-02-13
10702-016-06EA - Each10702-016573d2860-079a-4965-b5c9-f91ddde85e7d12013-02-13
10702-016-10EA - Each10702-016adae92bb-da61-47f1-8a0c-34f4404123ed12013-02-13
10702-016-50EA - Each10702-016185bfe82-a037-4950-b22b-74206f76051512013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-016INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.]15Current NDC, Legacy NDC, 6 package rows20250322_dc80228c-acae-44dc-9762-19bd1669bf45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN41af7776-36bc-4820-b635-e7c69f26997e104
310992indomethacin 75 MG Extended Release Oral CapsuleSCD41af7776-36bc-4820-b635-e7c69f26997e104
310992indomethacin 75 MG Extended Release Oral CapsulePSNdc80228c-acae-44dc-9762-19bd1669bf4515
310992indomethacin 75 MG Extended Release Oral CapsuleSCDdc80228c-acae-44dc-9762-19bd1669bf4515
310992indomethacin 75 MG Extended Release Oral CapsulePSN85014b51-1354-4d16-9995-3ee33a7155fa13
310992indomethacin 75 MG Extended Release Oral CapsuleSCD85014b51-1354-4d16-9995-3ee33a7155fa13
310992indomethacin 75 MG Extended Release Oral CapsulePSN5a65b650-ea9b-4d0d-b62f-5971df1e62b410
310992indomethacin 75 MG Extended Release Oral CapsuleSCD5a65b650-ea9b-4d0d-b62f-5971df1e62b410
310992indomethacin 75 MG Extended Release Oral CapsulePSN429e9731-cc5d-4089-bf4a-81ec22824c9e2
310992indomethacin 75 MG Extended Release Oral CapsulePSN6569dfd1-0164-4241-b508-ccd540d1e8582
310992indomethacin 75 MG Extended Release Oral CapsuleSCD429e9731-cc5d-4089-bf4a-81ec22824c9e2
310992indomethacin 75 MG Extended Release Oral CapsuleSCD6569dfd1-0164-4241-b508-ccd540d1e8582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-016-0110702001601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01) 2009-03-060000-00-00NoNoCurrent
10702-016-031070200160330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-03) 2011-02-020000-00-00NoNoCurrent
10702-016-061070200160660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-06) 2009-03-060000-00-00NoNoCurrent
10702-016-091070200160990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-09) 2011-02-020000-00-00NoNoCurrent
10702-016-10107020016101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-10) 2009-03-060000-00-00NoNoCurrent
10702-016-5010702001650500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-50) 2009-03-060000-00-00NoNoCurrent