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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091276-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB2010-12-22
A091276-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091276-001AB
A091276-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091276-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091276-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091276-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091276-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091276-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091276-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091276-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091276-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091276-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091276-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091276-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091276-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091276-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091276-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091276-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091276-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091276-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091276-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XXE1CET956Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197817Internal RxNorm lookup
197818Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7ed39e2-5431-4e47-935c-c7441d058f94Available on FDA.report

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 [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
AMMONIAINACTIVE INGREDIENT5138Q19F1XINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINREMEDYREPACK INC.bf93022c-a965-49c5-a852-c59e580d7d912026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.009097a5-2c1e-4f5d-8054-896cf896cb3d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.99d7a84b-c755-47be-9d2d-1223162b0a422026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINBryant Ranch Prepackbf11f5a0-f2ee-499a-8d54-9d557cc668412026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.1bb80a9f-def3-4228-ab04-a0c2a117a2b92026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINCoupler LLC51266787-b50e-bc15-e063-6394a90ad16f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINSt. Mary's Medical Park Pharmacy6312c9a6-d4d3-eb1f-e053-2991aa0a5e682026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.b4cf01d1-0d71-4f0f-97a5-07a59744149f2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINREMEDYREPACK INC.16238287-d4b0-4afa-8483-1f4ae250a6252026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINRedPharm Drug, Inc.4d9ef14a-4812-4fcf-e054-00144ff8d46c2026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINA-S Medication Solutions7755391e-ede3-4a32-854c-736dc6dd2ee32026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINA-S Medication Solutions927af761-2f37-4e81-a86e-d4fb17cc18972026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNorthwind Health Company, LLCc9f4eda2-5c8f-72eb-e053-2a95a90a06be2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNorthwind Health Company, LLCdb0f1127-ebd8-636c-e053-2a95a90a4d442026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINGlenmark Pharmaceuticals Inc., USAf7ed39e2-5431-4e47-935c-c7441d058f942025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 68462-302
IndomethacinINDOMETHACINA-S Medication Solutions175a2d81-0d0f-46a3-aaaa-1732982d85fd2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINBryant Ranch Prepack9ce37860-407f-47c7-a64c-62b6cc7292982024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNuCare Pharmaceuticals, Inc.503455d9-471e-554f-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
INDOMETHACININDOMETHACINDIRECT RX4d9a253a-f014-4fab-e054-00144ff8d46c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINProficient Rx LP86c94559-b453-4e61-a76c-6962872f06552022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276

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