neo-synalar

Generic: neomycin sulfate and fluocinolone acetonide

Labeler: medimetriks pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neo-synalar
Generic Name neomycin sulfate and fluocinolone acetonide
Labeler medimetriks pharmaceuticals
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .25 mg/g, neomycin sulfate 3.5 mg/g

Manufacturer
Medimetriks Pharmaceuticals

Identifiers & Regulatory

Product NDC 43538-940
Product ID 43538-940_4b6c5088-fd92-4793-8010-f2b20f9fe44a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA060700
Listing Expiration 2026-12-31
Marketing Start 1963-06-11

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 43538940
Hyphenated Format 43538-940

Supplemental Identifiers

RxCUI
1191359 1542994
UNII
0CD5FD6S2M 057Y626693
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 neo-synalar (source: ndc)
Generic Name neomycin sulfate and fluocinolone acetonide (source: ndc)
Application Number ANDA060700 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
  • 3.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE
  • 4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBE
source: ndc

Packages (2)

43538-940-60 1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE 43538-940-99 4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBE

Ingredients (2)

fluocinolone acetonide (.25 mg/g) neomycin sulfate (3.5 mg/g)

Linked Drug Pages (1)

Neo-Synalar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4b6c5088-fd92-4793-8010-f2b20f9fe44a", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M", "057Y626693"], "rxcui": ["1191359", "1542994"], "spl_set_id": ["1141956e-8a4c-4f80-95d1-f15bdb57fdf6"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Medimetriks Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (43538-940-60)  / 60 g in 1 TUBE", "package_ndc": "43538-940-60", "marketing_start_date": "19630611"}, {"sample": false, "description": "4 TUBE in 1 CARTON (43538-940-99)  / 3 g in 1 TUBE", "package_ndc": "43538-940-99", "marketing_start_date": "19630611"}], "brand_name": "Neo-Synalar", "product_id": "43538-940_4b6c5088-fd92-4793-8010-f2b20f9fe44a", "dosage_form": "CREAM", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "43538-940", "generic_name": "neomycin sulfate and fluocinolone acetonide", "labeler_name": "Medimetriks Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neo-Synalar", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".25 mg/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}], "application_number": "ANDA060700", "marketing_category": "ANDA", "marketing_start_date": "19630611", "listing_expiration_date": "20261231"}