pimecrolimus

Generic: pimecrolimus

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name pimecrolimus
Generic Name pimecrolimus
Labeler oceanside pharmaceuticals
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

pimecrolimus 10 mg/g

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-111
Product ID 68682-111_7234f339-90cb-4fbf-9477-6bd577fcc009
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021302
Listing Expiration 2026-12-31
Marketing Start 2018-11-26

Pharmacologic Class

Established (EPC)
calcineurin inhibitor immunosuppressant [epc]
Mechanism of Action
calcineurin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682111
Hyphenated Format 68682-111

Supplemental Identifiers

RxCUI
562806
UNII
7KYV510875
NUI
N0000175457 N0000175458

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 pimecrolimus (source: ndc)
Generic Name pimecrolimus (source: ndc)
Application Number NDA021302 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68682-111-02) / 60 g in 1 TUBE
source: ndc

Packages (1)

68682-111-02 1 TUBE in 1 CARTON (68682-111-02) / 60 g in 1 TUBE

Ingredients (1)

pimecrolimus (10 mg/g)

Linked Drug Pages (1)

Pimecrolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7234f339-90cb-4fbf-9477-6bd577fcc009", "openfda": {"nui": ["N0000175457", "N0000175458"], "unii": ["7KYV510875"], "rxcui": ["562806"], "spl_set_id": ["6601e43e-ce7d-446a-8568-8e7b24b86f06"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68682-111-02)  / 60 g in 1 TUBE", "package_ndc": "68682-111-02", "marketing_start_date": "20181126"}], "brand_name": "Pimecrolimus", "product_id": "68682-111_7234f339-90cb-4fbf-9477-6bd577fcc009", "dosage_form": "CREAM", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "68682-111", "generic_name": "Pimecrolimus", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pimecrolimus", "active_ingredients": [{"name": "PIMECROLIMUS", "strength": "10 mg/g"}], "application_number": "NDA021302", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20181126", "listing_expiration_date": "20261231"}