tacrolimus

Generic: tacrolimus

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler strides pharma science limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 5 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-722
Product ID 64380-722_48cd3633-d3c0-4197-aa6b-033887913404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090687
Listing Expiration 2026-12-31
Marketing Start 2020-10-05

Pharmacologic Class

Classes
calcineurin inhibitor immunosuppressant [epc] calcineurin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380722
Hyphenated Format 64380-722

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0364380721062 0364380720065 0364380722069
UNII
WM0HAQ4WNM

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 ANDA090687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (64380-722-01) / 10 CAPSULE in 1 BLISTER PACK
  • 100 CAPSULE in 1 CONTAINER (64380-722-06)
source: ndc

Packages (2)

64380-722-01 10 BLISTER PACK in 1 CARTON (64380-722-01) / 10 CAPSULE in 1 BLISTER PACK 64380-722-06 100 CAPSULE in 1 CONTAINER (64380-722-06)

Ingredients (1)

tacrolimus (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": "48cd3633-d3c0-4197-aa6b-033887913404", "openfda": {"upc": ["0364380721062", "0364380720065", "0364380722069"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["ed7d1495-3585-409d-94f1-b3d2469d222c"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (64380-722-01)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "64380-722-01", "marketing_start_date": "20201005"}, {"sample": false, "description": "100 CAPSULE in 1 CONTAINER (64380-722-06)", "package_ndc": "64380-722-06", "marketing_start_date": "20201005"}], "brand_name": "Tacrolimus", "product_id": "64380-722_48cd3633-d3c0-4197-aa6b-033887913404", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "64380-722", "generic_name": "Tacrolimus", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA090687", "marketing_category": "ANDA", "marketing_start_date": "20201005", "listing_expiration_date": "20261231"}