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United States · US · US:76420-029_ead13cff-b9d2-cdc1-e053-2a95a90adf09
Indomethacin
Orange BookUNIISPLATC C01EB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeC01EB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1176420029011 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-01)
- ndc1176420029022 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-02)
- ndc1176420029077 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-07)
- ndc11764200291414 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-14)
Annotations
UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A201807
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": "76420-029_ead13cff-b9d2-cdc1-e053-2a95a90adf09",
"productndc": "76420-029",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "201807",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Sep 28, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDOMETHACIN",
"proprietary_name": "Indomethacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201807",
"marketing_category": "ANDA",
"nonproprietary_name": "Indomethacin",
"start_marketing_date": "20150724",
"active_numerator_strength": "75"
}Related drugs
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- 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
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