🇺🇸
United States · US · US:65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4
Indomethacin
Orange BookUNIISPLATC C01EB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC01EB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11651625060330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)
- ndc11651625060660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06)
- ndc11651625060990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09)
- ndc116516250610100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10)
- ndc1165162506111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11)
- ndc116516250650500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50)
Annotations
UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A091549
AB
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": "65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4",
"productndc": "65162-506",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "091549",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Dec 1, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDOMETHACIN",
"proprietary_name": "Indomethacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091549",
"marketing_category": "ANDA",
"nonproprietary_name": "Indomethacin",
"start_marketing_date": "20101206",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code C01EB03.
- GBBerlind 75 Retard capsulesTillomed Laboratories Ltd
- GBFlexin-25 Continus tabletsNapp Pharmaceuticals Ltd
- GBFlexin-50 Continus tabletsNapp Pharmaceuticals Ltd
- GBFlexin-75 Continus tabletsNapp Pharmaceuticals Ltd
- GBIndocid 100mg suppositoriesNecessity Supplies Ltd
- GBIndocid 100mg suppositoriesAspen Pharma Trading Ltd
- GBIndocid 25mg capsulesOrganon Pharma (UK) Ltd
- GBIndocid 50mg capsulesOrganon Pharma (UK) Ltd
Access this data programmatically
Query Indomethacin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.