NDC 43538-940

Neo-Synalar

Neomycin Sulfate And Fluocinolone Acetonide

Neo-Synalar is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Medimetriks Pharmaceuticals. The primary component is Neomycin Sulfate; Fluocinolone Acetonide.

• Product ID: 43538-940_f03e2c0f-822c-42cd-bf7d-487c753d944a
• NDC: 43538-940
• Product Type: Human Prescription Drug
• Proprietary Name: Neo-Synalar
• Generic Name: Neomycin Sulfate And Fluocinolone Acetonide
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 1963-06-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA060700
• Labeler Name: Medimetriks Pharmaceuticals
• Substance Name: NEOMYCIN SULFATE; FLUOCINOLONE ACETONIDE
• Active Ingredient Strength: 4 mg/g; mg/g
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43538-940-60

1 TUBE in 1 CARTON (43538-940-60) > 60 g in 1 TUBE

• Marketing Start Date: 1963-06-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43538-940-99 [43538094099]

Neo-Synalar CREAM

• Marketing Category: ANDA
• Application Number: ANDA060700
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1963-06-11

NDC 43538-940-60 [43538094060]

Neo-Synalar CREAM

• Marketing Category: ANDA
• Application Number: ANDA060700
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1963-06-11

Drug Details

Active Ingredients

Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g

OpenFDA Data

• SPL SET ID: 1141956e-8a4c-4f80-95d1-f15bdb57fdf6
• Manufacturer:
  • Medimetriks Pharmaceuticals
• UNII:
  • 0CD5FD6S2M
  • 057Y626693
• RxNorm Concept Unique ID - RxCUI:
  • 1542994
  • 1191359

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

Medicade Reported Pricing

43538094060 NEO-SYNALAR 0.5%-0.025% CREAM

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "Neo-Synalar" or generic name "Neomycin Sulfate And Fluocinolone Acetonide"

NDC	Brand Name	Generic Name
43538-940	Neo-Synalar	neomycin sulfate and fluocinolone acetonide
43538-941	Neo-Synalar	neomycin sulfate and fluocinolone acetonide