tretinoin (microsphere)

Generic: tretinoin

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin (microsphere)
Generic Name tretinoin
Labeler mayne pharma
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tretinoin .8 mg/g

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 68308-777
Product ID 68308-777_7c0103a9-019d-4bc4-b4f5-df7d89bfd11d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215609
Listing Expiration 2026-12-31
Marketing Start 2024-10-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308777
Hyphenated Format 68308-777

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 (microsphere) (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 (68308-777-50) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

68308-777-50 1 BOTTLE, PUMP in 1 CARTON (68308-777-50) / 50 g in 1 BOTTLE, PUMP

Ingredients (1)

tretinoin (.8 mg/g)

Linked Drug Pages (1)

Tretinoin (Microsphere) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7c0103a9-019d-4bc4-b4f5-df7d89bfd11d", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["1488045"], "spl_set_id": ["ed2103ee-c9d5-4b3d-b525-318cf67be050"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68308-777-50)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "68308-777-50", "marketing_start_date": "20241025"}], "brand_name": "Tretinoin (Microsphere)", "product_id": "68308-777_7c0103a9-019d-4bc4-b4f5-df7d89bfd11d", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68308-777", "generic_name": "tretinoin", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin (Microsphere)", "active_ingredients": [{"name": "TRETINOIN", "strength": ".8 mg/g"}], "application_number": "ANDA215609", "marketing_category": "ANDA", "marketing_start_date": "20241025", "listing_expiration_date": "20261231"}