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United States · US · US:10702-016_30a4fdec-3f89-034c-e063-6294a90aa786
INDOMETHACIN
Orange BookUNIISPLATC C01EB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKVK-Tech, Inc.
CountryUS (United States)
ATC codeC01EB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc111070201601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01)
- ndc11107020160330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-03)
- ndc11107020160660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-06)
- ndc11107020160990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-09)
- ndc1110702016101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-10)
- ndc111070201650500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-50)
Annotations
UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
A079175
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": "10702-016_30a4fdec-3f89-034c-e063-6294a90aa786",
"productndc": "10702-016",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "079175",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Mar 6, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDOMETHACIN",
"proprietary_name": "INDOMETHACIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA079175",
"marketing_category": "ANDA",
"nonproprietary_name": "Indomethacin",
"start_marketing_date": "20090306",
"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
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