tretinoin

Generic: tretinoin

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler padagis us llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

tretinoin .25 mg/g

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-2225
Product ID 0574-2225_a25193b8-414f-4dfc-8ddc-8c5f92758279
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075264
Listing Expiration 2026-12-31
Marketing Start 2017-06-15

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05742225
Hyphenated Format 0574-2225

Supplemental Identifiers

RxCUI
106302 106303 198300 313450 313451
UNII
5688UTC01R
NUI
N0000175607 M0018962

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 tretinoin (source: ndc)
Generic Name tretinoin (source: ndc)
Application Number ANDA075264 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0574-2225-20) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0574-2225-45) / 45 g in 1 TUBE
source: ndc

Packages (2)

0574-2225-20 1 TUBE in 1 CARTON (0574-2225-20) / 20 g in 1 TUBE 0574-2225-45 1 TUBE in 1 CARTON (0574-2225-45) / 45 g in 1 TUBE

Ingredients (1)

tretinoin (.25 mg/g)

Linked Drug Pages (1)

TRETINOIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a25193b8-414f-4dfc-8ddc-8c5f92758279", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["106302", "106303", "198300", "313450", "313451"], "spl_set_id": ["4889c7f8-37d0-4f1a-9829-bca107806586"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0574-2225-20)  / 20 g in 1 TUBE", "package_ndc": "0574-2225-20", "marketing_start_date": "20170615"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0574-2225-45)  / 45 g in 1 TUBE", "package_ndc": "0574-2225-45", "marketing_start_date": "20170615"}], "brand_name": "TRETINOIN", "product_id": "0574-2225_a25193b8-414f-4dfc-8ddc-8c5f92758279", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0574-2225", "generic_name": "tretinoin", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRETINOIN", "active_ingredients": [{"name": "TRETINOIN", "strength": ".25 mg/g"}], "application_number": "ANDA075264", "marketing_category": "ANDA", "marketing_start_date": "20170615", "listing_expiration_date": "20261231"}