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 OINTMENT
Routes
TOPICAL
Active Ingredients

tacrolimus 1 mg/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-534
Product ID 68462-534_7443dde6-3783-407b-b78e-d50e9ffbb9e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210393
Listing Expiration 2026-12-31
Marketing Start 2018-04-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462534
Hyphenated Format 68462-534

Supplemental Identifiers

RxCUI
313189 314266
UPC
0368462881941 0368462534946
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 ANDA210393 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68462-534-35) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68462-534-65) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68462-534-94) / 100 g in 1 TUBE
source: ndc

Packages (3)

68462-534-35 1 TUBE in 1 CARTON (68462-534-35) / 30 g in 1 TUBE 68462-534-65 1 TUBE in 1 CARTON (68462-534-65) / 60 g in 1 TUBE 68462-534-94 1 TUBE in 1 CARTON (68462-534-94) / 100 g in 1 TUBE

Ingredients (1)

tacrolimus (1 mg/g)

Linked Drug Pages (1)

Tacrolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7443dde6-3783-407b-b78e-d50e9ffbb9e8", "openfda": {"upc": ["0368462881941", "0368462534946"], "unii": ["WM0HAQ4WNM"], "rxcui": ["313189", "314266"], "spl_set_id": ["c2d2e3a1-f346-4245-b445-6dd44e371180"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68462-534-35)  / 30 g in 1 TUBE", "package_ndc": "68462-534-35", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-534-65)  / 60 g in 1 TUBE", "package_ndc": "68462-534-65", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-534-94)  / 100 g in 1 TUBE", "package_ndc": "68462-534-94", "marketing_start_date": "20180416"}], "brand_name": "Tacrolimus", "product_id": "68462-534_7443dde6-3783-407b-b78e-d50e9ffbb9e8", "dosage_form": "OINTMENT", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "68462-534", "generic_name": "Tacrolimus", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tacrolimus", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/g"}], "application_number": "ANDA210393", "marketing_category": "ANDA", "marketing_start_date": "20180416", "listing_expiration_date": "20261231"}