pimecrolimus

Generic: pimecrolimus

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

Drug Facts

Product Profile

Brand Name pimecrolimus
Generic Name pimecrolimus
Labeler actavis pharma, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

pimecrolimus 10 mg/g

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2944
Product ID 0591-2944_a3f0bc92-796c-4f74-8c7a-63001b4e9e43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209345
Listing Expiration 2026-12-31
Marketing Start 2018-12-27

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 05912944
Hyphenated Format 0591-2944

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 ANDA209345 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 30 g in 1 TUBE (0591-2944-30)
  • 60 g in 1 TUBE (0591-2944-60)
  • 100 g in 1 TUBE (0591-2944-87)
source: ndc

Packages (3)

0591-2944-30 30 g in 1 TUBE (0591-2944-30) 0591-2944-60 60 g in 1 TUBE (0591-2944-60) 0591-2944-87 100 g in 1 TUBE (0591-2944-87)

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": "a3f0bc92-796c-4f74-8c7a-63001b4e9e43", "openfda": {"nui": ["N0000175457", "N0000175458"], "unii": ["7KYV510875"], "rxcui": ["562806"], "spl_set_id": ["d5b0403a-065f-42e3-96d6-7dcb9ab127d3"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 TUBE (0591-2944-30)", "package_ndc": "0591-2944-30", "marketing_start_date": "20181227"}, {"sample": false, "description": "60 g in 1 TUBE (0591-2944-60)", "package_ndc": "0591-2944-60", "marketing_start_date": "20181227"}, {"sample": false, "description": "100 g in 1 TUBE (0591-2944-87)", "package_ndc": "0591-2944-87", "marketing_start_date": "20181227"}], "brand_name": "pimecrolimus", "product_id": "0591-2944_a3f0bc92-796c-4f74-8c7a-63001b4e9e43", "dosage_form": "CREAM", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "0591-2944", "generic_name": "pimecrolimus", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pimecrolimus", "active_ingredients": [{"name": "PIMECROLIMUS", "strength": "10 mg/g"}], "application_number": "ANDA209345", "marketing_category": "ANDA", "marketing_start_date": "20181227", "listing_expiration_date": "20261231"}