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United States · US · US:71656-064_339e0417-4d1a-e168-e063-6294a90a50bb
hydrocortisone and acetic acid
Orange BookUNIISPLATC G01AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSaptalis Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG01AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171656064101 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
Q40Q9N063P
ACETIC ACID
RxCUI 168
Orange Book
N012770
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": "71656-064_339e0417-4d1a-e168-e063-6294a90a50bb",
"productndc": "71656-064",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "012770",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "2%;1%",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"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": "NDA012770",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "hydrocortisone and acetic acid otic",
"start_marketing_date": "20240223",
"active_numerator_strength": "20.75; 10.375"
}Related drugs
Other records sharing ATC code G01AD.
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