FDA.reportPublic FDA data

Indomethacin

Product NDC
63629-8994
11-digit product format
636298994
Labeler code
63629
Product ID
63629-8994_3b5a34fe-e05d-4320-ade2-61ea1e73a840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
A091240-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB2011-04-12
A091240-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORALAB2011-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091240-001AB
A091240-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12a50c72e98297…
2026-08-01 22:54:322026-06A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091240-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091240-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINSt. Mary's Medical Park Pharmacy205fc4e7-e118-509e-e063-6394a90a78e62026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.ce866d3a-7bea-4d82-9b7d-79e8a294c1412026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.d66ada00-3ece-4b71-8c59-a0db48a2db802026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINA-S Medication Solutionsd2997707-1541-4f5d-8c8d-70b0a13be8b22026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPreferred Pharmaceuticals, Inc.3785c914-0037-49ef-b6f5-a5e868ae490b2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
INDOMETHACININDOMETHACINDIRECT RX7e7175d7-5e43-4151-9702-88ac2cd44ef62026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINNorthwind Health Company, LLCdffe9b95-3cb6-4c4e-e053-2a95a90a93282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.971c4d53-7876-4f42-ba2d-c391714fa3412025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINA-S Medication Solutions5b05b8bc-4df0-4175-bf53-72129fb21b502025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepacka329976b-4a01-42ea-a666-0ac99ed2522e2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINCamber Pharmaceuticals, Inc.1ce9c3c5-0cf7-4760-988d-2559adcfb2002025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff72025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack67b16cf2-e24c-4fe3-8d74-e63549b7659f2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepackb1bb9349-21e4-4e6a-9916-3aac6c4d01b82025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack3fd56b7d-2799-4211-9a58-c6c1dc8c70dc2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
ndc (product): 63629-8994
IndomethacinINDOMETHACINBryant Ranch Prepack2f4a5796-5317-4caa-83e4-0595fe844df42025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINAvPAKbcaa0e51-a2fc-cf74-027a-1964e38c5e4e2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack9236d783-d7b8-4486-94c6-5ecd876bc4752024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack56e19868-3973-4f1b-b80f-1f7daf1f1c222024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepackafbb24fd-3695-4a30-a8a6-36239e35a14f2024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
3fd56b7d-2799-4211-9a58-c6c1dc8c70dcAvailable 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
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
63629-8994-1Indomethacin30 in 1 BOTTLECAPSULE30102
63629-8994-2Indomethacin60 in 1 BOTTLECAPSULE60102
63629-8994-3Indomethacin90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8994-1EA - Each63629-899481641be3-9f9e-402b-aafd-02bd59c34e7012022-03-09
63629-8994-2EA - Each63629-8994447a0a54-f900-4990-9bc2-28a3dc1ffd2912022-03-09
63629-8994-3EA - Each63629-89948853308b-ddb8-4b5d-a05b-887ff0772ac612022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8994INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20250330_3fd56b7d-2799-4211-9a58-c6c1dc8c70dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102
197818indomethacin 50 MG Oral CapsuleSCD3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8994-16362989940130 CAPSULE in 1 BOTTLE (63629-8994-1) 30 capsule2021-12-070000-00-00NoNoCurrent
63629-8994-26362989940260 CAPSULE in 1 BOTTLE (63629-8994-2) 60 capsule2021-12-070000-00-00NoNoCurrent
63629-8994-36362989940390 CAPSULE in 1 BOTTLE (63629-8994-3) 90 capsule2021-12-070000-00-00NoNoCurrent