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United States · US · US:68462-325_e729f88c-b2c8-4462-98be-7184de95b01d
indomethacin
Orange BookUNIISPLATC C01EB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC01EB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116846232501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01)
- ndc116846232505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05)
- ndc1168462325101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-10)
- ndc11684623256060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-60)
- ndc11684623259090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-90)
Annotations
UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A203501
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": "68462-325_e729f88c-b2c8-4462-98be-7184de95b01d",
"productndc": "68462-325",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "203501",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Jun 22, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDOMETHACIN",
"proprietary_name": "indomethacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203501",
"marketing_category": "ANDA",
"nonproprietary_name": "indomethacin",
"start_marketing_date": "20170622",
"active_numerator_strength": "75"
}Related drugs
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