tretinoin

Generic: tretinoin

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler alembic pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

tretinoin .25 mg/g

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-809
Product ID 62332-809_942c8089-c604-46d6-929d-3c2b07f00d39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218399
Listing Expiration 2027-12-31
Marketing Start 2025-08-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332809
Hyphenated Format 62332-809

Supplemental Identifiers

RxCUI
106302
UPC
0362332809455 0362332809202
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 ANDA218399 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (62332-809-20) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (62332-809-45) / 45 g in 1 TUBE
source: ndc

Packages (2)

62332-809-20 1 TUBE in 1 CARTON (62332-809-20) / 20 g in 1 TUBE 62332-809-45 1 TUBE in 1 CARTON (62332-809-45) / 45 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": "942c8089-c604-46d6-929d-3c2b07f00d39", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0362332809455", "0362332809202"], "unii": ["5688UTC01R"], "rxcui": ["106302"], "spl_set_id": ["872b3f8f-c073-4808-a106-840188ac7a00"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (62332-809-20)  / 20 g in 1 TUBE", "package_ndc": "62332-809-20", "marketing_start_date": "20250816"}, {"sample": false, "description": "1 TUBE in 1 CARTON (62332-809-45)  / 45 g in 1 TUBE", "package_ndc": "62332-809-45", "marketing_start_date": "20250816"}], "brand_name": "Tretinoin", "product_id": "62332-809_942c8089-c604-46d6-929d-3c2b07f00d39", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "62332-809", "generic_name": "Tretinoin", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": ".25 mg/g"}], "application_number": "ANDA218399", "marketing_category": "ANDA", "marketing_start_date": "20250816", "listing_expiration_date": "20271231"}