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United States · US · US:43063-777_5259ea38-cc94-13aa-e063-6294a90a1efc
Indomethacin
Orange BookUNIISPLATC C01EB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC01EB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11430637772020 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-20)
- ndc11430637773030 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-30)
Annotations
UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A091240
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XXE1CET956",
"rxcui": "5781",
"inchikey": "CGIGDMFJXJATDK-UHFFFAOYSA-N",
"display_name": "INDOMETHACIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"009097a5-2c1e-4f5d-8054-896cf896cb3d": {
"match": "brand_token",
"title": "INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "17",
"published_date": "2026-05-28"
}
},
"productid": "43063-777_5259ea38-cc94-13aa-e063-6294a90a1efc",
"productndc": "43063-777",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "091240",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Apr 12, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Apr 12, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDOMETHACIN",
"proprietary_name": "Indomethacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091240",
"marketing_category": "ANDA",
"nonproprietary_name": "Indomethacin",
"start_marketing_date": "20160519",
"active_numerator_strength": "50"
}Related drugs
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