Indomethacin

Product NDC
68462-302
11-digit product format
684620302
Labeler code
68462
Product ID
68462-302_bcf62935-0bd5-479f-9680-c5b4eba5a529
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
68462-302-01Indomethacin100 in 1 BOTTLECAPSULE10013
68462-302-05Indomethacin500 in 1 BOTTLECAPSULE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-302-01EA - Each68462-302a6b4e65f-2ab3-4db9-af82-68ed20a341b212012-07-24
68462-302-05EA - Each68462-302e3874211-a099-4fa5-9ad5-4bcb342163d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.]5
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
WATERINACTIVE INGREDIENT059QF0KO0RINDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP]3
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-302INDOMETHACIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 2 package rows20240810_f7ed39e2-5431-4e47-935c-c7441d058f94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN7755391e-ede3-4a32-854c-736dc6dd2ee343
197818indomethacin 50 MG Oral CapsulePSN7755391e-ede3-4a32-854c-736dc6dd2ee343
197817indomethacin 25 MG Oral CapsuleSCD7755391e-ede3-4a32-854c-736dc6dd2ee343
197818indomethacin 50 MG Oral CapsuleSCD7755391e-ede3-4a32-854c-736dc6dd2ee343
197818indomethacin 50 MG Oral CapsulePSN927af761-2f37-4e81-a86e-d4fb17cc189724
197818indomethacin 50 MG Oral CapsuleSCD927af761-2f37-4e81-a86e-d4fb17cc189724
197818indomethacin 50 MG Oral CapsulePSNbf93022c-a965-49c5-a852-c59e580d7d9122
197818indomethacin 50 MG Oral CapsuleSCDbf93022c-a965-49c5-a852-c59e580d7d9122
197818indomethacin 50 MG Oral CapsulePSN009097a5-2c1e-4f5d-8054-896cf896cb3d17
197818indomethacin 50 MG Oral CapsuleSCD009097a5-2c1e-4f5d-8054-896cf896cb3d17
197818indomethacin 50 MG Oral CapsulePSN99d7a84b-c755-47be-9d2d-1223162b0a4214
197818indomethacin 50 MG Oral CapsuleSCD99d7a84b-c755-47be-9d2d-1223162b0a4214
197817indomethacin 25 MG Oral CapsulePSNf7ed39e2-5431-4e47-935c-c7441d058f9413
197818indomethacin 50 MG Oral CapsulePSNf7ed39e2-5431-4e47-935c-c7441d058f9413
197817indomethacin 25 MG Oral CapsuleSCDf7ed39e2-5431-4e47-935c-c7441d058f9413
197818indomethacin 50 MG Oral CapsuleSCDf7ed39e2-5431-4e47-935c-c7441d058f9413
197818indomethacin 50 MG Oral CapsulePSN1bb80a9f-def3-4228-ab04-a0c2a117a2b912
197818indomethacin 50 MG Oral CapsuleSCD1bb80a9f-def3-4228-ab04-a0c2a117a2b912
197818indomethacin 50 MG Oral CapsulePSN9ce37860-407f-47c7-a64c-62b6cc72929810
197818indomethacin 50 MG Oral CapsulePSN6312c9a6-d4d3-eb1f-e053-2991aa0a5e6810
197818indomethacin 50 MG Oral CapsuleSCD9ce37860-407f-47c7-a64c-62b6cc72929810
197818indomethacin 50 MG Oral CapsuleSCD6312c9a6-d4d3-eb1f-e053-2991aa0a5e6810
197817indomethacin 25 MG Oral CapsulePSN4d9a253a-f014-4fab-e054-00144ff8d46c7
197818indomethacin 50 MG Oral CapsulePSN4d9a253a-f014-4fab-e054-00144ff8d46c7
197818indomethacin 50 MG Oral CapsulePSN4d9ef14a-4812-4fcf-e054-00144ff8d46c7
197817indomethacin 25 MG Oral CapsuleSCD4d9a253a-f014-4fab-e054-00144ff8d46c7
197818indomethacin 50 MG Oral CapsuleSCD4d9a253a-f014-4fab-e054-00144ff8d46c7
197818indomethacin 50 MG Oral CapsuleSCD4d9ef14a-4812-4fcf-e054-00144ff8d46c7
197818indomethacin 50 MG Oral CapsulePSN503455d9-471e-554f-e054-00144ff88e886
197818indomethacin 50 MG Oral CapsuleSCD503455d9-471e-554f-e054-00144ff88e886
197818indomethacin 50 MG Oral CapsulePSNa9b815a8-5e80-4a54-958c-6c307b87f3235
197818indomethacin 50 MG Oral CapsulePSNda46beba-5693-4c64-b1a8-9ccbe1d380945
197818indomethacin 50 MG Oral CapsuleSCDa9b815a8-5e80-4a54-958c-6c307b87f3235
197818indomethacin 50 MG Oral CapsuleSCDda46beba-5693-4c64-b1a8-9ccbe1d380945
197818indomethacin 50 MG Oral CapsulePSNb094eb04-3177-431d-b5ac-edc4804750a24
197818indomethacin 50 MG Oral CapsulePSNc9f4eda2-5c8f-72eb-e053-2a95a90a06be4
197818indomethacin 50 MG Oral CapsuleSCDb094eb04-3177-431d-b5ac-edc4804750a24
197818indomethacin 50 MG Oral CapsuleSCDc9f4eda2-5c8f-72eb-e053-2a95a90a06be4
197818indomethacin 50 MG Oral CapsulePSN9f082d89-d218-49e0-8fcb-0000b5eb04a53
197818indomethacin 50 MG Oral CapsuleSCD9f082d89-d218-49e0-8fcb-0000b5eb04a53
197818indomethacin 50 MG Oral CapsulePSN51266787-b50e-bc15-e063-6394a90ad16f1
197818indomethacin 50 MG Oral CapsuleSCD51266787-b50e-bc15-e063-6394a90ad16f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-302-0168462030201100 CAPSULE in 1 BOTTLE (68462-302-01) 100 capsule2010-12-220000-00-00NoNoCurrent
68462-302-0568462030205500 CAPSULE in 1 BOTTLE (68462-302-05) 500 capsule2010-12-220000-00-00NoNoCurrent