tretinoin

Generic: tretinoin

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler oceanside pharmaceuticals
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tretinoin .8 mg/g

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-515
Product ID 68682-515_c4ef7e4d-9c2e-4022-b7ab-b55962c1a58a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020475
Listing Expiration 2027-12-31
Marketing Start 2023-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682515
Hyphenated Format 68682-515

Supplemental Identifiers

RxCUI
313453 359050 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 NDA020475 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .8 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (68682-515-95) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

68682-515-95 1 BOTTLE, PUMP in 1 CARTON (68682-515-95) / 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": "c4ef7e4d-9c2e-4022-b7ab-b55962c1a58a", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["313453", "359050", "1488045"], "spl_set_id": ["d3c528d2-429d-4f37-9ebf-eee8b9fd3050"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68682-515-95)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "68682-515-95", "marketing_start_date": "20231201"}], "brand_name": "Tretinoin", "product_id": "68682-515_c4ef7e4d-9c2e-4022-b7ab-b55962c1a58a", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68682-515", "generic_name": "Tretinoin", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": ".8 mg/g"}], "application_number": "NDA020475", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231201", "listing_expiration_date": "20271231"}