tretinoin

Generic: tretinoin

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler endo usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tretinoin 10 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 10370-268
Product ID 10370-268_f124fad5-1e6a-4161-bc98-2b927e2df5d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201687
Listing Expiration 2026-12-31
Marketing Start 2012-10-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10370268
Hyphenated Format 10370-268

Supplemental Identifiers

RxCUI
199159
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 ANDA201687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (10370-268-01)
source: ndc

Packages (1)

10370-268-01 100 CAPSULE in 1 BOTTLE (10370-268-01)

Ingredients (1)

tretinoin (10 mg/1)

Linked Drug Pages (1)

Tretinoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f124fad5-1e6a-4161-bc98-2b927e2df5d2", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["199159"], "spl_set_id": ["9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (10370-268-01)", "package_ndc": "10370-268-01", "marketing_start_date": "20121024"}], "brand_name": "Tretinoin", "product_id": "10370-268_f124fad5-1e6a-4161-bc98-2b927e2df5d2", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "10370-268", "generic_name": "Tretinoin", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": "10 mg/1"}], "application_number": "ANDA201687", "marketing_category": "ANDA", "marketing_start_date": "20121024", "listing_expiration_date": "20261231"}