FDA.reportPublic FDA data

Indomethacin

Product NDC
68084-411
11-digit product format
680840411
Labeler code
68084
Product ID
68084-411_423d8198-e51f-90c2-e063-6294a90a1de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079175
Marketing category
ANDA
Marketing start
2010-03-26
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

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
ndc (product): 68084-411
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

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 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
310992Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a65b650-ea9b-4d0d-b62f-5971df1e62b4Available 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
68084-411-11Indomethacin1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE110
68084-411-21Indomethacin30 in 1 BOX, UNIT-DOSECAPSULE, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-411-11EA - Each68084-4110f845ef6-85c5-4599-9dd8-7fc10bdbd51012012-07-24
68084-411-21EA - Each68084-4115b73b70d-146f-4939-bf7d-91b3cd8065ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
SUCROSEINACTIVE INGREDIENTC151H8M554INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-411INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20241116_5a65b650-ea9b-4d0d-b62f-5971df1e62b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN5a65b650-ea9b-4d0d-b62f-5971df1e62b410
310992indomethacin 75 MG Extended Release Oral CapsuleSCD5a65b650-ea9b-4d0d-b62f-5971df1e62b410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-411-11680840411111 in 1 BLISTER PACKHistorical
68084-411-216808404112130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-411-21) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-411-11) 30 blister pack2010-03-260000-00-00NoNoCurrent