Indomethacin

Product NDC
31722-543
11-digit product format
317220543
Labeler code
31722
Product ID
31722-543_349de484-29cd-3e15-e063-6394a90a5aa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA091240
Marketing category
ANDA
Marketing start
2016-05-19
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
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
31722-543-01Indomethacin100 in 1 BOTTLECAPSULE1008
31722-543-01Indomethacin12 in 1 CASECAPSULE128
31722-543-05Indomethacin500 in 1 BOTTLECAPSULE5008
31722-543-05Indomethacin12 in 1 CASECAPSULE128
31722-543-10Indomethacin1000 in 1 BOTTLECAPSULE10008
31722-543-10Indomethacin12 in 1 CASECAPSULE128
31722-543-30Indomethacin12 in 1 CASECAPSULE128
31722-543-30Indomethacin30 in 1 BOTTLECAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-543-01EA - Each31722-543b6a75293-7242-4cc8-9e78-fb0a6a4485ad12012-07-24
31722-543-05EA - Each31722-54368f09d09-2e9f-4fda-88cd-37092edf77fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [DIRECT RX]3
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [DIRECT RX]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [DIRECT RX]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [DIRECT RX]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [DIRECT RX]3
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [PROFICIENT RX LP]2
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [AVPAK]1
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [AVPAK]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [AVPAK]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [AVPAK]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [AVPAK]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [AVPAK]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [AVPAK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [AVPAK]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [AVPAK]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-543INDOMETHACIN (INDOMETHACIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 8 package rows20250509_1ce9c3c5-0cf7-4760-988d-2559adcfb200.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSNafbb24fd-3695-4a30-a8a6-36239e35a14f106
197818indomethacin 50 MG Oral CapsuleSCDafbb24fd-3695-4a30-a8a6-36239e35a14f106
197818indomethacin 50 MG Oral CapsulePSN3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102
197818indomethacin 50 MG Oral CapsuleSCD3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102
197818indomethacin 50 MG Oral CapsulePSN4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7101
197818indomethacin 50 MG Oral CapsuleSCD4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7101
197817indomethacin 25 MG Oral CapsulePSNd2997707-1541-4f5d-8c8d-70b0a13be8b233
197818indomethacin 50 MG Oral CapsulePSNd2997707-1541-4f5d-8c8d-70b0a13be8b233
197817indomethacin 25 MG Oral CapsuleSCDd2997707-1541-4f5d-8c8d-70b0a13be8b233
197818indomethacin 50 MG Oral CapsuleSCDd2997707-1541-4f5d-8c8d-70b0a13be8b233
197817indomethacin 25 MG Oral CapsulePSN5b05b8bc-4df0-4175-bf53-72129fb21b5022
197818indomethacin 50 MG Oral CapsulePSN5b05b8bc-4df0-4175-bf53-72129fb21b5022
197817indomethacin 25 MG Oral CapsuleSCD5b05b8bc-4df0-4175-bf53-72129fb21b5022
197818indomethacin 50 MG Oral CapsuleSCD5b05b8bc-4df0-4175-bf53-72129fb21b5022
197818indomethacin 50 MG Oral CapsulePSNd66ada00-3ece-4b71-8c59-a0db48a2db8015
197818indomethacin 50 MG Oral CapsuleSCDd66ada00-3ece-4b71-8c59-a0db48a2db8015
197818indomethacin 50 MG Oral CapsulePSNa329976b-4a01-42ea-a666-0ac99ed2522e9
197818indomethacin 50 MG Oral CapsuleSCDa329976b-4a01-42ea-a666-0ac99ed2522e9
197817indomethacin 25 MG Oral CapsulePSN1ce9c3c5-0cf7-4760-988d-2559adcfb2008
197818indomethacin 50 MG Oral CapsulePSN1ce9c3c5-0cf7-4760-988d-2559adcfb2008
197817indomethacin 25 MG Oral CapsuleSCD1ce9c3c5-0cf7-4760-988d-2559adcfb2008
197818indomethacin 50 MG Oral CapsuleSCD1ce9c3c5-0cf7-4760-988d-2559adcfb2008
197817indomethacin 25 MG Oral CapsulePSNbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7
197818indomethacin 50 MG Oral CapsulePSN7e7175d7-5e43-4151-9702-88ac2cd44ef67
197818indomethacin 50 MG Oral CapsulePSNbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7
197817indomethacin 25 MG Oral CapsuleSCDbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7
197818indomethacin 50 MG Oral CapsuleSCD7e7175d7-5e43-4151-9702-88ac2cd44ef67
197818indomethacin 50 MG Oral CapsuleSCDbcaa0e51-a2fc-cf74-027a-1964e38c5e4e7
197818indomethacin 50 MG Oral CapsulePSN66e3205b-eab1-4864-bf36-116e9d79fe3e6
197818indomethacin 50 MG Oral CapsuleSCD66e3205b-eab1-4864-bf36-116e9d79fe3e6
197818indomethacin 50 MG Oral CapsulePSN3e87e34a-6556-4b0f-e054-00144ff8d46c5
197818indomethacin 50 MG Oral CapsuleSCD3e87e34a-6556-4b0f-e054-00144ff8d46c5
197817indomethacin 25 MG Oral CapsulePSN67b16cf2-e24c-4fe3-8d74-e63549b7659f4
197818indomethacin 50 MG Oral CapsulePSN505a18fd-5072-4c66-9ee9-d654fc2b4e614
197818indomethacin 50 MG Oral CapsulePSN67b16cf2-e24c-4fe3-8d74-e63549b7659f4
197817indomethacin 25 MG Oral CapsuleSCD67b16cf2-e24c-4fe3-8d74-e63549b7659f4
197818indomethacin 50 MG Oral CapsuleSCD67b16cf2-e24c-4fe3-8d74-e63549b7659f4
197818indomethacin 50 MG Oral CapsuleSCD505a18fd-5072-4c66-9ee9-d654fc2b4e614
197818indomethacin 50 MG Oral CapsulePSN205fc4e7-e118-509e-e063-6394a90a78e63
197818indomethacin 50 MG Oral CapsulePSN891ab059-a11e-0f81-e053-2995a90a03bf3
197818indomethacin 50 MG Oral CapsuleSCD891ab059-a11e-0f81-e053-2995a90a03bf3
197818indomethacin 50 MG Oral CapsuleSCD205fc4e7-e118-509e-e063-6394a90a78e63
197818indomethacin 50 MG Oral CapsulePSN9131abdc-dd9c-22f1-e053-2a95a90ab0112
197818indomethacin 50 MG Oral CapsuleSCD9131abdc-dd9c-22f1-e053-2a95a90ab0112
197818indomethacin 50 MG Oral CapsulePSN971c4d53-7876-4f42-ba2d-c391714fa3411
197818indomethacin 50 MG Oral CapsuleSCD971c4d53-7876-4f42-ba2d-c391714fa3411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-543-013172205430112 BOTTLE in 1 CASE (31722-543-01) / 100 CAPSULE in 1 BOTTLE12 bottle2016-05-190000-00-00NoNoCurrent
31722-543-053172205430512 BOTTLE in 1 CASE (31722-543-05) / 500 CAPSULE in 1 BOTTLE12 bottle2016-05-190000-00-00NoNoCurrent
31722-543-103172205431012 BOTTLE in 1 CASE (31722-543-10) / 1000 CAPSULE in 1 BOTTLE12 bottle2016-05-190000-00-00NoNoCurrent
31722-543-303172205433012 BOTTLE in 1 CASE (31722-543-30) / 30 CAPSULE in 1 BOTTLE12 bottle2016-05-190000-00-00NoNoCurrent