FDA.reportPublic FDA data

Indomethacin

Product NDC
65162-506
11-digit product format
651620506
Labeler code
65162
Product ID
65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA091549
Marketing category
ANDA
Marketing start
2010-12-06
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
65162-506-03Indomethacin30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3029
65162-506-06Indomethacin60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6029
65162-506-09Indomethacin90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9029
65162-506-10Indomethacin100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10029
65162-506-11Indomethacin1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100029
65162-506-50Indomethacin500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-506-03EA - Each65162-5062bb06218-8eab-4ea3-babc-3acff841a3e112012-07-24
65162-506-06EA - Each65162-50681b8c104-e113-4e70-b9ca-daf14bedcaf412012-07-24
65162-506-09EA - Each65162-50685deac06-5486-48fd-8569-87f30735ac8612012-07-24
65162-506-50EA - Each65162-5061b93f822-6738-4ea2-947a-565fbf88218d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]5
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-506INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]29Current NDC, Legacy NDC, 6 package rows20241222_dbad7e61-2347-43b1-a422-9183e41c10ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSNdbad7e61-2347-43b1-a422-9183e41c10ea29
310992indomethacin 75 MG Extended Release Oral CapsuleSCDdbad7e61-2347-43b1-a422-9183e41c10ea29
310992indomethacin 75 MG Extended Release Oral CapsulePSN17c9214f-0eba-0088-e054-00144ff88e885
310992indomethacin 75 MG Extended Release Oral CapsuleSCD17c9214f-0eba-0088-e054-00144ff88e885
310992indomethacin 75 MG Extended Release Oral CapsulePSN29a6b41c-accb-4b12-92d1-cda19c2148a51
310992indomethacin 75 MG Extended Release Oral CapsuleSCD29a6b41c-accb-4b12-92d1-cda19c2148a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-506-036516205060330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03) 2010-12-060000-00-00NoNoCurrent
65162-506-066516205060660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06) 2010-12-060000-00-00NoNoCurrent
65162-506-096516205060990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09) 2010-12-060000-00-00NoNoCurrent
65162-506-1065162050610100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10) 2010-12-060000-00-00NoNoCurrent
65162-506-11651620506111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11) 2010-12-060000-00-00NoNoCurrent
65162-506-5065162050650500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50) 2010-12-060000-00-00NoNoCurrent