atralin

Generic: tretinoin

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name atralin
Generic Name tretinoin
Labeler bausch health us, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tretinoin .05 g/100g

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 13548-070
Product ID 13548-070_77e095d6-f941-44ef-ad04-08d607843d65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022070
Listing Expiration 2026-12-31
Marketing Start 2007-07-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13548070
Hyphenated Format 13548-070

Supplemental Identifiers

RxCUI
245723 749329
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 atralin (source: ndc)
Generic Name tretinoin (source: ndc)
Application Number NDA022070 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .05 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBE
source: ndc

Packages (1)

13548-070-45 1 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBE

Ingredients (1)

tretinoin (.05 g/100g)

Linked Drug Pages (1)

Atralin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "77e095d6-f941-44ef-ad04-08d607843d65", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["245723", "749329"], "spl_set_id": ["b6b45969-a64a-4ce3-b3b6-157d2568a301"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (13548-070-45)  / 45 g in 1 TUBE", "package_ndc": "13548-070-45", "marketing_start_date": "20070726"}], "brand_name": "Atralin", "product_id": "13548-070_77e095d6-f941-44ef-ad04-08d607843d65", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "13548-070", "generic_name": "Tretinoin", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atralin", "active_ingredients": [{"name": "TRETINOIN", "strength": ".05 g/100g"}], "application_number": "NDA022070", "marketing_category": "NDA", "marketing_start_date": "20070726", "listing_expiration_date": "20261231"}