tacrolimus

Generic: tacrolimus

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-685
Product ID 68462-685_13e3f94c-d4c5-4b5b-a51a-0e87eadc5718
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206662
Listing Expiration 2027-12-31
Marketing Start 2020-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462685
Hyphenated Format 68462-685

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0368462686010 0368462687017 0368462685013
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 ANDA206662 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68462-685-01)
source: ndc

Packages (1)

68462-685-01 100 CAPSULE in 1 BOTTLE (68462-685-01)

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": "13e3f94c-d4c5-4b5b-a51a-0e87eadc5718", "openfda": {"upc": ["0368462686010", "0368462687017", "0368462685013"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["4b310c6b-e035-4e44-9573-4001d58b2ad5"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68462-685-01)", "package_ndc": "68462-685-01", "marketing_start_date": "20201110"}], "brand_name": "tacrolimus", "product_id": "68462-685_13e3f94c-d4c5-4b5b-a51a-0e87eadc5718", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "68462-685", "generic_name": "tacrolimus", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA206662", "marketing_category": "ANDA", "marketing_start_date": "20201110", "listing_expiration_date": "20271231"}