tretinoin

Generic: tretinoin

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

Drug Facts

Product Profile

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

tretinoin .25 mg/g

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-809
Product ID 46708-809_dc155719-fc32-4f08-a9db-b59da2f80759
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218399
Listing Expiration 2026-12-31
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 46708809
Hyphenated Format 46708-809

Supplemental Identifiers

RxCUI
106302
UPC
0346708809454
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 (46708-809-20) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (46708-809-45) / 45 g in 1 TUBE
source: ndc

Packages (2)

46708-809-20 1 TUBE in 1 CARTON (46708-809-20) / 20 g in 1 TUBE 46708-809-45 1 TUBE in 1 CARTON (46708-809-45) / 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": "dc155719-fc32-4f08-a9db-b59da2f80759", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0346708809454"], "unii": ["5688UTC01R"], "rxcui": ["106302"], "spl_set_id": ["4e96fb71-14f4-4789-91af-ba94b0879162"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (46708-809-20)  / 20 g in 1 TUBE", "package_ndc": "46708-809-20", "marketing_start_date": "20250816"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-809-45)  / 45 g in 1 TUBE", "package_ndc": "46708-809-45", "marketing_start_date": "20250816"}], "brand_name": "Tretinoin", "product_id": "46708-809_dc155719-fc32-4f08-a9db-b59da2f80759", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "46708-809", "generic_name": "Tretinoin", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "20261231"}