tretinoin

Generic: tretinoin

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler northstar rx llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

tretinoin 1 mg/g

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-250
Product ID 16714-250_39809802-b48a-ea14-e063-6394a90a1380
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211645
Listing Expiration 2026-12-31
Marketing Start 2019-01-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714250
Hyphenated Format 16714-250

Supplemental Identifiers

RxCUI
198300
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 ANDA211645 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (16714-250-01) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (16714-250-02) / 45 g in 1 TUBE
source: ndc

Packages (2)

16714-250-01 1 TUBE in 1 CARTON (16714-250-01) / 20 g in 1 TUBE 16714-250-02 1 TUBE in 1 CARTON (16714-250-02) / 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": "39809802-b48a-ea14-e063-6394a90a1380", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["198300"], "spl_set_id": ["de3e7308-1212-4727-b541-568a84dac48a"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (16714-250-01)  / 20 g in 1 TUBE", "package_ndc": "16714-250-01", "marketing_start_date": "20220225"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16714-250-02)  / 45 g in 1 TUBE", "package_ndc": "16714-250-02", "marketing_start_date": "20220225"}], "brand_name": "Tretinoin", "product_id": "16714-250_39809802-b48a-ea14-e063-6394a90a1380", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "16714-250", "generic_name": "Tretinoin", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": "1 mg/g"}], "application_number": "ANDA211645", "marketing_category": "ANDA", "marketing_start_date": "20190122", "listing_expiration_date": "20261231"}