tretinoin

Generic: tretinoin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler mylan pharmaceuticals inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tretinoin .1 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8085
Product ID 0378-8085_96edaee2-b74e-4f7b-947f-1addc75402ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA017955
Listing Expiration 2026-12-31
Marketing Start 2019-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788085
Hyphenated Format 0378-8085

Supplemental Identifiers

RxCUI
106302 106303 198300 313450 313451
UPC
0303788082450 0303788083457 0303788086151
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 NDA017955 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-8085-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0378-8085-45) / 45 g in 1 TUBE
source: ndc

Packages (2)

0378-8085-15 1 TUBE in 1 CARTON (0378-8085-15) / 15 g in 1 TUBE 0378-8085-45 1 TUBE in 1 CARTON (0378-8085-45) / 45 g in 1 TUBE

Ingredients (1)

tretinoin (.1 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": "96edaee2-b74e-4f7b-947f-1addc75402ea", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0303788082450", "0303788083457", "0303788086151"], "unii": ["5688UTC01R"], "rxcui": ["106302", "106303", "198300", "313450", "313451"], "spl_set_id": ["ba377a5e-e48a-4bd9-9d76-929d70793396"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-8085-15)  / 15 g in 1 TUBE", "package_ndc": "0378-8085-15", "marketing_start_date": "20190812"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0378-8085-45)  / 45 g in 1 TUBE", "package_ndc": "0378-8085-45", "marketing_start_date": "20190812"}], "brand_name": "Tretinoin", "product_id": "0378-8085_96edaee2-b74e-4f7b-947f-1addc75402ea", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0378-8085", "generic_name": "Tretinoin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": ".1 mg/g"}], "application_number": "NDA017955", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190812", "listing_expiration_date": "20261231"}