tacrolimus

Generic: tacrolimus

Labeler: hangzhou zhongmei huadong pharmaceutical co., ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler hangzhou zhongmei huadong pharmaceutical co., ltd
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus anhydrous .5 mg/1

Manufacturer
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd

Identifiers & Regulatory

Product NDC 65897-0009
Product ID 65897-0009_39a2918e-2da4-a843-e063-6294a90a9fec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210929
Listing Expiration 2026-12-31
Marketing Start 2025-07-11

Pharmacologic Class

Established (EPC)
calcineurin inhibitor immunosuppressant [epc]
Mechanism of Action
calcineurin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 658970009
Hyphenated Format 65897-0009

Supplemental Identifiers

RxCUI
198377 313190
UNII
Y5L2157C4J
NUI
N0000175457 N0000175458

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tacrolimus (source: ndc)
Generic Name tacrolimus (source: ndc)
Application Number ANDA210929 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1 BAG in 1 CARTON (65897-0009-1) / 10 BLISTER PACK in 1 BAG / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

65897-0009-1 1 BAG in 1 CARTON (65897-0009-1) / 10 BLISTER PACK in 1 BAG / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

tacrolimus anhydrous (.5 mg/1)

Linked Drug Pages (1)

Tacrolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39a2918e-2da4-a843-e063-6294a90a9fec", "openfda": {"nui": ["N0000175457", "N0000175458"], "unii": ["Y5L2157C4J"], "rxcui": ["198377", "313190"], "spl_set_id": ["759cf905-7406-4d1b-a1a8-10068cb11f04"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]"], "manufacturer_name": ["Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 CARTON (65897-0009-1)  / 10 BLISTER PACK in 1 BAG / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "65897-0009-1", "marketing_start_date": "20250711"}], "brand_name": "Tacrolimus", "product_id": "65897-0009_39a2918e-2da4-a843-e063-6294a90a9fec", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "65897-0009", "generic_name": "Tacrolimus", "labeler_name": "Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS ANHYDROUS", "strength": ".5 mg/1"}], "application_number": "ANDA210929", "marketing_category": "ANDA", "marketing_start_date": "20250711", "listing_expiration_date": "20261231"}