🇺🇸
United States · US · US:68462-534_15dcd504-ee3e-4f0f-a765-55e31511641e
Tacrolimus
Orange BookUNIISPLATC L04AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeL04AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1168462534351 TUBE in 1 CARTON (68462-534-35) / 30 g in 1 TUBE
- ndc1168462534651 TUBE in 1 CARTON (68462-534-65) / 60 g in 1 TUBE
- ndc1168462534941 TUBE in 1 CARTON (68462-534-94) / 100 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A210393
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WM0HAQ4WNM",
"rxcui": "484288",
"inchikey": "NWJQLQGQZSIBAF-MLAUYUEBSA-N",
"display_name": "TACROLIMUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f": {
"match": "brand_token",
"title": "TACROLIMUS (TACROLIMUS) CAPSULE [BIOCON PHARMA INC.]",
"spl_version": "12",
"published_date": "2026-05-26"
}
},
"productid": "68462-534_15dcd504-ee3e-4f0f-a765-55e31511641e",
"productndc": "68462-534",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "210393",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Apr 16, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03%",
"product_no": "002",
"approval_date": "Aug 16, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TACROLIMUS",
"proprietary_name": "Tacrolimus",
"active_ingred_unit": "mg/g",
"application_number": "ANDA210393",
"marketing_category": "ANDA",
"nonproprietary_name": "Tacrolimus",
"start_marketing_date": "20180416",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L04AD02.
Access this data programmatically
Query Tacrolimus and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.