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 CREAM
Routes
TOPICAL
Active Ingredients

tretinoin .25 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-079
Product ID 21922-079_0eb1525d-c374-4904-9456-84fd7de635ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217831
Listing Expiration 2027-12-31
Marketing Start 2025-07-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922079
Hyphenated Format 21922-079

Supplemental Identifiers

RxCUI
106302 198300
UPC
0321922077254 0321922079258 0321922079067 0321922077063
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 ANDA217831 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-079-06) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-079-25) / 20 g in 1 TUBE
source: ndc

Packages (2)

21922-079-06 1 TUBE in 1 CARTON (21922-079-06) / 45 g in 1 TUBE 21922-079-25 1 TUBE in 1 CARTON (21922-079-25) / 20 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": "0eb1525d-c374-4904-9456-84fd7de635ed", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0321922077254", "0321922079258", "0321922079067", "0321922077063"], "unii": ["5688UTC01R"], "rxcui": ["106302", "198300"], "spl_set_id": ["5e3fb8ea-234c-4be2-95a7-d139e069cf98"], "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 TUBE in 1 CARTON (21922-079-06)  / 45 g in 1 TUBE", "package_ndc": "21922-079-06", "marketing_start_date": "20250711"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-079-25)  / 20 g in 1 TUBE", "package_ndc": "21922-079-25", "marketing_start_date": "20250711"}], "brand_name": "Tretinoin", "product_id": "21922-079_0eb1525d-c374-4904-9456-84fd7de635ed", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "21922-079", "generic_name": "Tretinoin", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": ".25 mg/g"}], "application_number": "ANDA217831", "marketing_category": "ANDA", "marketing_start_date": "20250711", "listing_expiration_date": "20271231"}