FDA.reportPublic FDA data

Application 091240

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE;ORAL25MGNoNo
002INDOMETHACININDOMETHACINCAPSULE;ORAL50MGNoNo

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
ndc (product): 43063-773
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.d66ada00-3ece-4b71-8c59-a0db48a2db802026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
ndc (product): 43063-777
IndomethacinINDOMETHACINA-S Medication Solutionsd2997707-1541-4f5d-8c8d-70b0a13be8b22026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
ndc (product): 50090-0050
ndc (product): 50090-0052
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
ndc (product): 61919-130
IndomethacinINDOMETHACINNorthwind Health Company, LLCdffe9b95-3cb6-4c4e-e053-2a95a90a93282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
ndc (product): 51655-963
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
ndc (product): 50090-0051
ndc (product): 50090-0053
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
ndc (product): 31722-542
ndc (product): 31722-543
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
ndc (product): 63629-8993
IndomethacinINDOMETHACINAvPAKbcaa0e51-a2fc-cf74-027a-1964e38c5e4e2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
ndc (product): 50268-430
ndc (product): 50268-431
IndomethacinINDOMETHACINBryant Ranch Prepack9236d783-d7b8-4486-94c6-5ecd876bc4752024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
ndc (product): 63629-1913
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
ndc (product): 63629-1914

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 116 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-542IndomethacinIndomethacinCamber PharmaceuticalsANDACurrent
31722-542IndomethacinIndomethacinCamber Pharmaceuticals, Inc.ANDACurrent
31722-542IndomethacinIndomethacinCamber Pharmaceuticals, Inc.ANDACurrent
31722-543IndomethacinIndomethacinCamber PharmaceuticalsANDACurrent
31722-543IndomethacinIndomethacinCamber Pharmaceuticals, Inc.ANDACurrent
31722-543IndomethacinIndomethacinCamber Pharmaceuticals, Inc.ANDACurrent
43063-773IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-773IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-773IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-773IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-773IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-773IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-777IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-777IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-777IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-777IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-777IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-883IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0050IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0050IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0050IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0050IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0051IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0051IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0051IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0052IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0052IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0053IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0053IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50268-430IndomethacinIndomethacinAvPAKANDACurrent
50268-430IndomethacinIndomethacinAvPAKANDACurrent
50268-430IndomethacinIndomethacinAvPAKANDACurrent
50268-430IndomethacinIndomethacinAvPAKANDACurrent
50268-431IndomethacinIndomethacinAvPAKANDACurrent
50268-431IndomethacinIndomethacinAvPAKANDACurrent
50268-431IndomethacinIndomethacinAvPAKANDACurrent
50268-431IndomethacinIndomethacinAvPAKANDACurrent
50436-0875IndomethacinIndomethacinUnit Dose ServicesANDACurrent
51655-963IndomethacinIndomethacinNorthwind PharmaceuticalsANDACurrent
52959-081INDOMETHACININDOMETHACINH.J. Harkins Co., Inc.ANDACurrent
53002-3050IndomethacinIndomethacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-3050IndomethacinIndomethacinRPK Pharmaceuticals, Inc.ANDACurrent
55700-536IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-536IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-536IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-536IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-536IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-537IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-537IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-537IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-537IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-537IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-537IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-129INDOMETHACININDOMETHACINDirect RxANDACurrent
61919-129INDOMETHACININDOMETHACINDirect RxANDACurrent
61919-130INDOMETHACININDOMETHACINDIRECT RXANDACurrent
61919-130INDOMETHACININDOMETHACINDirect_RxANDACurrent
61919-130INDOMETHACININDOMETHACINDirect_RxANDACurrent
61919-130INDOMETHACININDOMETHACINDIRECT RXANDACurrent
63187-282IndomethacinIndomethacinProficient Rx LPANDACurrent
63187-282IndomethacinIndomethacinProficient Rx LPANDACurrent
63629-1913IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-1913IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-1914IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-1914IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-6333IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-6333IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-7171IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-7171IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-7171IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-7171IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-8066IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-8066IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-8993IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-8994IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
65977-5042IndomethacinIndomethacinHetero Drugs Ltd.,ANDACurrent
65977-5043IndomethacinIndomethacinHetero Drugs Ltd.,ANDACurrent
66267-119IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-119IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-120IndomethacinIndomethacinNuCare Pharmaceuticals, IANDACurrent