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United States · US · US:68462-609_693578a9-44f8-442b-b186-ccb367cc7cf0
Pimecrolimus
Orange BookUNIISPLATC D11AH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD11AH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1168462609351 TUBE in 1 CARTON (68462-609-35) / 30 g in 1 TUBE
- ndc1168462609651 TUBE in 1 CARTON (68462-609-65) / 60 g in 1 TUBE
- ndc1168462609941 TUBE in 1 CARTON (68462-609-94) / 100 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
7KYV510875
PIMECROLIMUS
RxCUI 321952
Orange Book
A211769
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7KYV510875",
"rxcui": "321952",
"inchikey": "KASDHRXLYQOAKZ-XDSKOBMDSA-N",
"display_name": "PIMECROLIMUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"6601e43e-ce7d-446a-8568-8e7b24b86f06": {
"match": "brand_token",
"title": "PIMECROLIMUS CREAM [OCEANSIDE PHARMACEUTICALS]",
"spl_version": "4",
"published_date": "2026-05-21"
}
},
"productid": "68462-609_693578a9-44f8-442b-b186-ccb367cc7cf0",
"productndc": "68462-609",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "211769",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1%",
"product_no": "001",
"approval_date": "Aug 29, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIMECROLIMUS",
"proprietary_name": "Pimecrolimus",
"active_ingred_unit": "mg/g",
"application_number": "ANDA211769",
"marketing_category": "ANDA",
"nonproprietary_name": "Pimecrolimus",
"start_marketing_date": "20190829",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code D11AH02.
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