tacrolimus

Generic: tacrolimus

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler dr. reddy's laboratories limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 1 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-526
Product ID 55111-526_706bafff-d629-291c-5ce5-83d74a638860
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090509
Listing Expiration 2026-12-31
Marketing Start 2010-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111526
Hyphenated Format 55111-526

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0355111527015 0355111525011 0355111526018
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 ANDA090509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55111-526-01) / 100 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-526-05) / 500 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-526-30) / 30 CAPSULE in 1 BOTTLE
  • 10 BLISTER PACK in 1 CARTON (55111-526-78) / 10 CAPSULE in 1 BLISTER PACK (55111-526-79)
source: ndc

Packages (4)

55111-526-01 1 BOTTLE in 1 CARTON (55111-526-01) / 100 CAPSULE in 1 BOTTLE 55111-526-05 1 BOTTLE in 1 CARTON (55111-526-05) / 500 CAPSULE in 1 BOTTLE 55111-526-30 1 BOTTLE in 1 CARTON (55111-526-30) / 30 CAPSULE in 1 BOTTLE 55111-526-78 10 BLISTER PACK in 1 CARTON (55111-526-78) / 10 CAPSULE in 1 BLISTER PACK (55111-526-79)

Ingredients (1)

tacrolimus (1 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": "706bafff-d629-291c-5ce5-83d74a638860", "openfda": {"upc": ["0355111527015", "0355111525011", "0355111526018"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["61dee012-43af-0e9a-3843-9b9b91e022c4"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-526-01)  / 100 CAPSULE in 1 BOTTLE", "package_ndc": "55111-526-01", "marketing_start_date": "20100514"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-526-05)  / 500 CAPSULE in 1 BOTTLE", "package_ndc": "55111-526-05", "marketing_start_date": "20100514"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-526-30)  / 30 CAPSULE in 1 BOTTLE", "package_ndc": "55111-526-30", "marketing_start_date": "20100514"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-526-78)  / 10 CAPSULE in 1 BLISTER PACK (55111-526-79)", "package_ndc": "55111-526-78", "marketing_start_date": "20100514"}], "brand_name": "Tacrolimus", "product_id": "55111-526_706bafff-d629-291c-5ce5-83d74a638860", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "55111-526", "generic_name": "Tacrolimus", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/1"}], "application_number": "ANDA090509", "marketing_category": "ANDA", "marketing_start_date": "20100514", "listing_expiration_date": "20261231"}