tacrolimus

Generic: tacrolimus

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler bpi labs llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus 5 mg/1

Manufacturer
BPI Labs LLC

Identifiers & Regulatory

Product NDC 54288-133
Product ID 54288-133_f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206651
Listing Expiration 2027-12-31
Marketing Start 2020-04-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288133
Hyphenated Format 54288-133

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0354288134019 0354288133012 0354288135016
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 ANDA206651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (54288-133-01)
source: ndc

Packages (1)

54288-133-01 100 CAPSULE in 1 BOTTLE (54288-133-01)

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": "f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9", "openfda": {"upc": ["0354288134019", "0354288133012", "0354288135016"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["3e8bc65e-8048-4073-8e45-570330603000"], "manufacturer_name": ["BPI Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (54288-133-01)", "package_ndc": "54288-133-01", "marketing_start_date": "20200408"}], "brand_name": "Tacrolimus", "product_id": "54288-133_f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "54288-133", "generic_name": "Tacrolimus", "labeler_name": "BPI Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA206651", "marketing_category": "ANDA", "marketing_start_date": "20200408", "listing_expiration_date": "20271231"}