FDA.reportPublic FDA data

Indomethacin

Product NDC
71335-0756
Requested package NDC
71335-0756-4
11-digit product format
713350756
Labeler code
71335
Product ID
71335-0756_ffcf3ed7-eaad-44a9-b4ab-e272d52f3bbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201807
Marketing category
ANDA
Marketing start
2015-07-24
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
A201807-001INDOMETHACININDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALABRS2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201807-001AB

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 22:54:322026-06A201807-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALABRS2012-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201807-001AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINREMEDYREPACK INC.b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf302026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
IndomethacinINDOMETHACINSportpharm LLC12821a3a-b5f2-4415-84c9-0a30a4725f1e2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
IndomethacinINDOMETHACINNorthwind Health Company, LLCf2f59f63-fcda-2a80-e053-2995a90ab0872026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
IndomethacinINDOMETHACINBryant Ranch Prepackefa111d5-ade4-4944-97e4-3c37b8b14ea82025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
ndc (package): 71335-0756-4
ndc (product): 71335-0756
ndc11 (package): 71335075604
IndomethacinINDOMETHACINCamber Pharmaceuticals, Inc.12f62bae-5fc0-4f8d-a8b4-446524bd53d12025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
IndomethacinINDOMETHACINBryant Ranch Prepackd54d6e12-e827-4248-819a-de76afa703712025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
Indomethacin ERINDOMETHACINAdvanced Rx Pharmacy of Tennessee, LLCf4e8a719-ef9c-a2ef-e053-2995a90ad7882024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
IndomethacinINDOMETHACINBryant Ranch Prepackc6126527-5272-4477-8716-d05365a052252024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
IndomethacinINDOMETHACINProficient Rx LPac458b4b-95bb-4235-a447-e8c4ba7202572023-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807
IndomethacinINDOMETHACINAsclemed USA, Inc.dfdcdb27-07a0-47e6-b8da-d9c99045a0662022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201807
application number: ANDA201807

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
efa111d5-ade4-4944-97e4-3c37b8b14ea8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0756-1Indomethacin30 in 1 BOTTLECAPSULE, EXTENDED RELEASE308
71335-0756-2Indomethacin60 in 1 BOTTLECAPSULE, EXTENDED RELEASE608
71335-0756-3Indomethacin14 in 1 BOTTLECAPSULE, EXTENDED RELEASE148
71335-0756-4Indomethacin10 in 1 BOTTLECAPSULE, EXTENDED RELEASE108
71335-0756-5Indomethacin7 in 1 BOTTLECAPSULE, EXTENDED RELEASE78
71335-0756-6Indomethacin15 in 1 BOTTLECAPSULE, EXTENDED RELEASE158
71335-0756-7Indomethacin20 in 1 BOTTLECAPSULE, EXTENDED RELEASE208
71335-0756-8Indomethacin90 in 1 BOTTLECAPSULE, EXTENDED RELEASE908
71335-0756-9Indomethacin100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0756-2EA - Each71335-0756c1b97005-fac2-45b8-a2be-a56a45d43d6612019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0756INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 9 package rows20240828_efa111d5-ade4-4944-97e4-3c37b8b14ea8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSNefa111d5-ade4-4944-97e4-3c37b8b14ea88
310992indomethacin 75 MG Extended Release Oral CapsuleSCDefa111d5-ade4-4944-97e4-3c37b8b14ea88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0756-47133507560410 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0756-4) 2015-07-240000-00-00NoNoCurrent