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United States · US · US:51672-3007_395a20ab-856b-3f08-e063-6294a90aa48e
Hydrocortisone and Acetic Acid
Orange BookUNIISPLATC G01AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG01AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151672300711 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
Q40Q9N063P
ACETIC ACID
RxCUI 168
Orange Book
A088759
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q40Q9N063P",
"rxcui": "168",
"inchikey": "QTBSBXVTEAMEQO-UHFFFAOYSA-N",
"display_name": "ACETIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "AURICULAR (OTIC)",
"spl_meta": {
"bc751403-94f2-4f9d-b533-cf6186a40ceb": {
"match": "brand_token",
"title": "HYDROCORTISONE TABLET [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "12",
"published_date": "2026-05-27"
}
},
"productid": "51672-3007_395a20ab-856b-3f08-e063-6294a90aa48e",
"productndc": "51672-3007",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "088759",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "2%;1%",
"product_no": "001",
"approval_date": "Mar 4, 1985"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETIC ACID; HYDROCORTISONE",
"proprietary_name": "Hydrocortisone and Acetic Acid",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA088759",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrocortisone and Acetic Acid",
"start_marketing_date": "20050428",
"active_numerator_strength": "20.8; 10.4"
}Related drugs
Other records sharing ATC code G01AD.
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