FDA.reportPublic FDA data

INDOMETHACIN

Product NDC
68151-1733
11-digit product format
681511733
Labeler code
68151
Product ID
68151-1733_f68a2ea6-e62f-4a7b-8acb-64ebb0b89e37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA079175
Marketing category
ANDA
Marketing start
2009-03-06
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-1733IInactivated by FDA2026-07-31
excluded packagepackage68151-173368151-1733-8IInactivated by FDA2026-07-31

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079175-001INDOMETHACININDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2009-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079175-001AB

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 22:54:322026-06A079175-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2009-03-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079175-001AB1a50c72e98297…

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INDOMETHACININDOMETHACINBryant Ranch Prepack41af7776-36bc-4820-b635-e7c69f26997e2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079175
application number: ANDA079175
IndomethacinINDOMETHACINAmerican Health Packaging5a65b650-ea9b-4d0d-b62f-5971df1e62b42025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079175
application number: ANDA079175
INDOMETHACININDOMETHACINPD-Rx Pharmaceuticals, Inc.85014b51-1354-4d16-9995-3ee33a7155fa2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079175
application number: ANDA079175
INDOMETHACININDOMETHACINKVK-Tech, Inc.dc80228c-acae-44dc-9762-19bd1669bf452025-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079175
application number: ANDA079175

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-1733-82020-01-31C16284748780-19d75b9d0-4183-f424-e053-dadaa90a57ceINDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1733-8INDOMETHACIN1 in 1 BOTTLECAPSULE, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1733INDOMETHACIN CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20160616_429e9731-cc5d-4089-bf4a-81ec22824c9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN429e9731-cc5d-4089-bf4a-81ec22824c9e2
310992indomethacin 75 MG Extended Release Oral CapsuleSCD429e9731-cc5d-4089-bf4a-81ec22824c9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1733-8681511733081 in 1 BOTTLEHistorical