tretinoin

Generic: tretinoin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler aurobindo pharma limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tretinoin .1 mg/g

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-712
Product ID 59651-712_11e769a1-681a-4367-a0b6-a08ff62157f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218246
Listing Expiration 2026-12-31
Marketing Start 2025-01-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651712
Hyphenated Format 59651-712

Supplemental Identifiers

RxCUI
313450
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 ANDA218246 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (59651-712-14) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (59651-712-46) / 45 g in 1 TUBE
source: ndc

Packages (2)

59651-712-14 1 TUBE in 1 CARTON (59651-712-14) / 15 g in 1 TUBE 59651-712-46 1 TUBE in 1 CARTON (59651-712-46) / 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": "11e769a1-681a-4367-a0b6-a08ff62157f5", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["313450"], "spl_set_id": ["f64e45d7-bbc0-4da4-9ccb-e3941f22fdbe"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (59651-712-14)  / 15 g in 1 TUBE", "package_ndc": "59651-712-14", "marketing_start_date": "20250113"}, {"sample": false, "description": "1 TUBE in 1 CARTON (59651-712-46)  / 45 g in 1 TUBE", "package_ndc": "59651-712-46", "marketing_start_date": "20250113"}], "brand_name": "Tretinoin", "product_id": "59651-712_11e769a1-681a-4367-a0b6-a08ff62157f5", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "59651-712", "generic_name": "Tretinoin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": ".1 mg/g"}], "application_number": "ANDA218246", "marketing_category": "ANDA", "marketing_start_date": "20250113", "listing_expiration_date": "20261231"}