tretinoin

Generic: tretinoin

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler american health packaging
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tretinoin 10 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-075
Product ID 68084-075_41c2a834-9f5a-9820-e063-6294a90ad914
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201687
Listing Expiration 2026-12-31
Marketing Start 2013-07-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084075
Hyphenated Format 68084-075

Supplemental Identifiers

RxCUI
199159
UNII
5688UTC01R
NUI
N0000175607 M0018962

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
  • 3 BLISTER PACK in 1 CARTON (68084-075-21) / 10 CAPSULE in 1 BLISTER PACK (68084-075-11)
source: ndc

Packages (1)

68084-075-21 3 BLISTER PACK in 1 CARTON (68084-075-21) / 10 CAPSULE in 1 BLISTER PACK (68084-075-11)

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": "41c2a834-9f5a-9820-e063-6294a90ad914", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["199159"], "spl_set_id": ["b22d5a07-623a-4645-b87d-a151b86da8d5"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68084-075-21)  / 10 CAPSULE in 1 BLISTER PACK (68084-075-11)", "package_ndc": "68084-075-21", "marketing_start_date": "20130718"}], "brand_name": "Tretinoin", "product_id": "68084-075_41c2a834-9f5a-9820-e063-6294a90ad914", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68084-075", "generic_name": "Tretinoin", "labeler_name": "American Health Packaging", "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": "20130718", "listing_expiration_date": "20261231"}