NDC 0168-0279

Amcinonide

Amcinonide

Amcinonide is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Amcinonide.

• Product ID: 0168-0279_dda607c9-29ec-40bd-a925-cb74036f4790
• NDC: 0168-0279
• Product Type: Human Prescription Drug
• Proprietary Name: Amcinonide
• Generic Name: Amcinonide
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-04-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076096
• Labeler Name: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• Substance Name: AMCINONIDE
• Active Ingredient Strength: 1 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0168-0279-60

1 TUBE in 1 CARTON (0168-0279-60) > 60 g in 1 TUBE

• Marketing Start Date: 2014-04-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0279-60 [00168027960]

Amcinonide OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA076096
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-04-03
• Inactivation Date: 2020-01-31

NDC 0168-0279-30 [00168027930]

Amcinonide OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA076096
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-03
• Marketing End Date: 2012-03-01

Drug Details

Active Ingredients

Ingredient	Strength
AMCINONIDE	1 mg/g

OpenFDA Data

• SPL SET ID: 3a386f5e-530d-446b-a0fb-6b9a667ad23f
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • 423W026MA9
• RxNorm Concept Unique ID - RxCUI:
  • 197328

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Amcinonide" or generic name "Amcinonide"

NDC	Brand Name	Generic Name
0168-0278	Amcinonide	Amcinonide
0168-0279	Amcinonide	amcinonide
0168-0280	amcinonide	amcinonide
51672-4054	Amcinonide	Amcinonide
51672-4060	Amcinonide	Amcinonide