tretinoin

Generic: tretinoin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

tretinoin .5 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1394
Product ID 51672-1394_38ef297e-e4cb-0593-e063-6294a90a324d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211644
Listing Expiration 2026-12-31
Marketing Start 2019-01-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721394
Hyphenated Format 51672-1394

Supplemental Identifiers

RxCUI
106303
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 ANDA211644 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1394-0) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1394-9) / 45 g in 1 TUBE
source: ndc

Packages (2)

51672-1394-0 1 TUBE in 1 CARTON (51672-1394-0) / 20 g in 1 TUBE 51672-1394-9 1 TUBE in 1 CARTON (51672-1394-9) / 45 g in 1 TUBE

Ingredients (1)

tretinoin (.5 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": "38ef297e-e4cb-0593-e063-6294a90a324d", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["5688UTC01R"], "rxcui": ["106303"], "spl_set_id": ["2b0c8ee4-83a5-48f1-809a-9716131f7290"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1394-0)  / 20 g in 1 TUBE", "package_ndc": "51672-1394-0", "marketing_start_date": "20190125"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1394-9)  / 45 g in 1 TUBE", "package_ndc": "51672-1394-9", "marketing_start_date": "20190125"}], "brand_name": "Tretinoin", "product_id": "51672-1394_38ef297e-e4cb-0593-e063-6294a90a324d", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "51672-1394", "generic_name": "tretinoin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": ".5 mg/g"}], "application_number": "ANDA211644", "marketing_category": "ANDA", "marketing_start_date": "20190125", "listing_expiration_date": "20261231"}