tretinoin

Generic: tretinoin

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tretinoin .8 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-043
Product ID 21922-043_0b99d648-7ecd-4c6d-89a6-fd20a998d626
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215609
Listing Expiration 2026-12-31
Marketing Start 2023-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922043
Hyphenated Format 21922-043

Supplemental Identifiers

RxCUI
1488045
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 ANDA215609 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .8 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (21922-043-40) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

21922-043-40 1 BOTTLE, PUMP in 1 CARTON (21922-043-40) / 50 g in 1 BOTTLE, PUMP

Ingredients (1)

tretinoin (.8 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": "0b99d648-7ecd-4c6d-89a6-fd20a998d626", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["1488045"], "spl_set_id": ["57558405-42fa-40bb-a61c-48e030d976de"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (21922-043-40)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "21922-043-40", "marketing_start_date": "20230824"}], "brand_name": "TRETINOIN", "product_id": "21922-043_0b99d648-7ecd-4c6d-89a6-fd20a998d626", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "21922-043", "generic_name": "Tretinoin", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRETINOIN", "active_ingredients": [{"name": "TRETINOIN", "strength": ".8 mg/g"}], "application_number": "ANDA215609", "marketing_category": "ANDA", "marketing_start_date": "20230824", "listing_expiration_date": "20261231"}