oralone

Generic: triamcinolone acetonide

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

Drug Facts

Product Profile

Brand Name oralone
Generic Name triamcinolone acetonide
Labeler sun pharmaceutical industries, inc.
Dosage Form PASTE
Routes
DENTAL
Active Ingredients

triamcinolone acetonide 1 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1335
Product ID 51672-1335_3961db48-e5fb-c2d8-e063-6294a90ab8ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070730
Listing Expiration 2026-12-31
Marketing Start 1986-10-01

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721335
Hyphenated Format 51672-1335

Supplemental Identifiers

RxCUI
1085728 1085767
UNII
F446C597KA
NUI
N0000175576 N0000175450

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 oralone (source: ndc)
Generic Name triamcinolone acetonide (source: ndc)
Application Number ANDA070730 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1335-5) / 5 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1335-8) / 7.5 g in 1 TUBE
source: ndc

Packages (2)

51672-1335-5 1 TUBE in 1 CARTON (51672-1335-5) / 5 g in 1 TUBE 51672-1335-8 1 TUBE in 1 CARTON (51672-1335-8) / 7.5 g in 1 TUBE

Ingredients (1)

triamcinolone acetonide (1 mg/g)

Linked Drug Pages (1)

Oralone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "3961db48-e5fb-c2d8-e063-6294a90ab8ba", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["F446C597KA"], "rxcui": ["1085728", "1085767"], "spl_set_id": ["ac1e2116-795e-4c20-974d-11fa07cf0fa7"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1335-5)  / 5 g in 1 TUBE", "package_ndc": "51672-1335-5", "marketing_start_date": "19861001"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1335-8)  / 7.5 g in 1 TUBE", "package_ndc": "51672-1335-8", "marketing_start_date": "19861001"}], "brand_name": "Oralone", "product_id": "51672-1335_3961db48-e5fb-c2d8-e063-6294a90ab8ba", "dosage_form": "PASTE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-1335", "generic_name": "Triamcinolone Acetonide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oralone", "active_ingredients": [{"name": "TRIAMCINOLONE ACETONIDE", "strength": "1 mg/g"}], "application_number": "ANDA070730", "marketing_category": "ANDA", "marketing_start_date": "19861001", "listing_expiration_date": "20261231"}