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United States · US · US:53489-478_2524fd49-5789-e388-e063-6394a90a2c9b
SULINDAC
Orange BookUNIISPLATC M01AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeM01AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc115348947801100 TABLET in 1 BOTTLE, PLASTIC (53489-478-01)
- ndc11534894780250 TABLET in 1 BOTTLE, PLASTIC (53489-478-02)
- ndc115348947803250 TABLET in 1 BOTTLE, PLASTIC (53489-478-03)
- ndc115348947805500 TABLET in 1 BOTTLE, PLASTIC (53489-478-05)
- ndc11534894780660 TABLET in 1 BOTTLE, PLASTIC (53489-478-06)
- ndc1153489478101000 TABLET in 1 BOTTLE, PLASTIC (53489-478-10)
Annotations
UNII (FDA Substance ID)
184SNS8VUH
SULINDAC
RxCUI 10237
Orange Book
A072050
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "184SNS8VUH",
"rxcui": "10237",
"inchikey": "MLKXDPUZXIRXEP-MFOYZWKCSA-N",
"display_name": "SULINDAC",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6041acc2-5e8a-4d3c-bf50-7e9447748e2b": {
"match": "brand_token",
"title": "SULINDAC TABLET [A-S MEDICATION SOLUTIONS]",
"spl_version": "16",
"published_date": "2026-05-11"
}
},
"productid": "53489-478_2524fd49-5789-e388-e063-6394a90a2c9b",
"productndc": "53489-478",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "072050",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "Apr 17, 1991"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULINDAC",
"proprietary_name": "SULINDAC",
"active_ingred_unit": "mg/1",
"application_number": "ANDA072050",
"marketing_category": "ANDA",
"nonproprietary_name": "sulindac",
"start_marketing_date": "20090904",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code M01AB02.
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