tacrolimus

Generic: tacrolimus

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler biocon pharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-014
Product ID 70377-014_d8b4d1c6-1cec-ce5b-2df0-a355f6e9f762
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212297
Listing Expiration 2026-12-31
Marketing Start 2020-12-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70377014
Hyphenated Format 70377-014

Supplemental Identifiers

RxCUI
198377 198378 313190
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 ANDA212297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70377-014-11)
source: ndc

Packages (1)

70377-014-11 100 CAPSULE in 1 BOTTLE (70377-014-11)

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": "d8b4d1c6-1cec-ce5b-2df0-a355f6e9f762", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70377-014-11)", "package_ndc": "70377-014-11", "marketing_start_date": "20201223"}], "brand_name": "Tacrolimus", "product_id": "70377-014_d8b4d1c6-1cec-ce5b-2df0-a355f6e9f762", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "70377-014", "generic_name": "Tacrolimus", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA212297", "marketing_category": "ANDA", "marketing_start_date": "20201223", "listing_expiration_date": "20261231"}