tacrolimus

Generic: tacrolimus

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tacrolimus
Generic Name tacrolimus
Labeler northstar rx llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-098
Product ID 16714-098_a24bfd52-5fd3-4980-8e64-5ba6b0d93d67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206662
Listing Expiration 2026-12-31
Marketing Start 2021-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714098
Hyphenated Format 16714-098

Supplemental Identifiers

RxCUI
198377 198378 313190
UPC
0316714098012 0316714099019 0316714100012
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 (16714-098-01)
source: ndc

Packages (1)

16714-098-01 100 CAPSULE in 1 BOTTLE (16714-098-01)

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": "a24bfd52-5fd3-4980-8e64-5ba6b0d93d67", "openfda": {"upc": ["0316714098012", "0316714099019", "0316714100012"], "unii": ["WM0HAQ4WNM"], "rxcui": ["198377", "198378", "313190"], "spl_set_id": ["875f4962-557e-4e12-ad7b-cb5fb6f2a65f"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (16714-098-01)", "package_ndc": "16714-098-01", "marketing_start_date": "20210331"}], "brand_name": "tacrolimus", "product_id": "16714-098_a24bfd52-5fd3-4980-8e64-5ba6b0d93d67", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "16714-098", "generic_name": "tacrolimus", "labeler_name": "NORTHSTAR RX LLC", "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": "20210331", "listing_expiration_date": "20261231"}