FDA.reportPublic FDA data

Indomethacin

Product NDC
31722-565
11-digit product format
317220565
Labeler code
31722
Product ID
31722-565_349e2ce2-f399-926c-e063-6294a90a9185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA201807
Marketing category
ANDA
Marketing start
2015-07-24
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
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-565-01Indomethacin100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1007
31722-565-05Indomethacin500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5007
31722-565-10Indomethacin1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10007
31722-565-30Indomethacin30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
31722-565-60Indomethacin60 in 1 BOTTLECAPSULE, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-565-01EA - Each31722-5659bfd94a2-a3a8-47b5-85d0-030e2a11c00212013-03-03
31722-565-60EA - Each31722-5655383c6bf-40f9-4155-bc83-f95ee58831f812013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
POTASSIUM CATIONINACTIVE INGREDIENT295O53K152INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
POTASSIUM CATIONINACTIVE INGREDIENT295O53K152INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
POTASSIUM CATIONINACTIVE INGREDIENT295O53K152INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN (INDOMETHACIN ) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-565INDOMETHACIN (INDOMETHACIN) CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 5 package rows20250509_12f62bae-5fc0-4f8d-a8b4-446524bd53d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSNc6126527-5272-4477-8716-d05365a05225104
310992indomethacin 75 MG Extended Release Oral CapsuleSCDc6126527-5272-4477-8716-d05365a05225104
310992indomethacin 75 MG Extended Release Oral CapsulePSNd54d6e12-e827-4248-819a-de76afa70371101
310992indomethacin 75 MG Extended Release Oral CapsuleSCDd54d6e12-e827-4248-819a-de76afa70371101
310992indomethacin 75 MG Extended Release Oral CapsulePSNb3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf3023
310992indomethacin 75 MG Extended Release Oral CapsuleSCDb3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf3023
310992indomethacin 75 MG Extended Release Oral CapsulePSNefa111d5-ade4-4944-97e4-3c37b8b14ea88
310992indomethacin 75 MG Extended Release Oral CapsuleSCDefa111d5-ade4-4944-97e4-3c37b8b14ea88
310992indomethacin 75 MG Extended Release Oral CapsulePSN12f62bae-5fc0-4f8d-a8b4-446524bd53d17
310992indomethacin 75 MG Extended Release Oral CapsuleSCD12f62bae-5fc0-4f8d-a8b4-446524bd53d17
310992indomethacin 75 MG Extended Release Oral CapsulePSNf2f59f63-fcda-2a80-e053-2995a90ab0874
310992indomethacin 75 MG Extended Release Oral CapsuleSCDf2f59f63-fcda-2a80-e053-2995a90ab0874
310992indomethacin 75 MG Extended Release Oral CapsulePSN12821a3a-b5f2-4415-84c9-0a30a4725f1e3
310992indomethacin 75 MG Extended Release Oral CapsuleSCD12821a3a-b5f2-4415-84c9-0a30a4725f1e3
310992indomethacin 75 MG Extended Release Oral CapsulePSNac458b4b-95bb-4235-a447-e8c4ba7202572
310992indomethacin 75 MG Extended Release Oral CapsulePSNdfdcdb27-07a0-47e6-b8da-d9c99045a0662
310992indomethacin 75 MG Extended Release Oral CapsulePSN1b8ee98e-3905-0c53-e054-00144ff8d46c2
310992indomethacin 75 MG Extended Release Oral CapsulePSNf4e8a719-ef9c-a2ef-e053-2995a90ad7882
310992indomethacin 75 MG Extended Release Oral CapsuleSCDdfdcdb27-07a0-47e6-b8da-d9c99045a0662
310992indomethacin 75 MG Extended Release Oral CapsuleSCDac458b4b-95bb-4235-a447-e8c4ba7202572
310992indomethacin 75 MG Extended Release Oral CapsuleSCD1b8ee98e-3905-0c53-e054-00144ff8d46c2
310992indomethacin 75 MG Extended Release Oral CapsuleSCDf4e8a719-ef9c-a2ef-e053-2995a90ad7882
310992indomethacin 75 MG Extended Release Oral CapsulePSNef9444e9-fc20-4139-ae74-ae9268e44a211
310992indomethacin 75 MG Extended Release Oral CapsuleSCDef9444e9-fc20-4139-ae74-ae9268e44a211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-565-0131722056501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-01) 2015-07-240000-00-00NoNoCurrent
31722-565-0531722056505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-05) 2015-07-240000-00-00NoNoCurrent
31722-565-10317220565101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-10) 2015-07-240000-00-00NoNoCurrent
31722-565-303172205653030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-30) 2015-07-240000-00-00NoNoCurrent
31722-565-603172205656060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-60) 2015-07-240000-00-00NoNoCurrent