NDC 16110-869

AZELEX

Azelaic Acid

AZELEX is a Cutaneous Cream in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Azelaic Acid.

• Product ID: 16110-869_4e21d6b6-e1de-4601-b80e-0e8bd1c859dd
• NDC: 16110-869
• Product Type: Human Prescription Drug
• Proprietary Name: AZELEX
• Generic Name: Azelaic Acid
• Dosage Form: Cream
• Route of Administration: CUTANEOUS
• Marketing Start Date: 2018-09-24
• Marketing Category: NDA / NDA
• Application Number: NDA020428
• Labeler Name: Almirall, LLC
• Substance Name: AZELAIC ACID
• Active Ingredient Strength: 0 g/g
• Pharm Classes: Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 16110-869-30

1 TUBE in 1 CARTON (16110-869-30) > 30 g in 1 TUBE

• Marketing Start Date: 2019-07-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16110-869-30 [16110086930]

AZELEX CREAM

• Marketing Category: NDA
• Application Number: NDA020428
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-07-12

NDC 16110-869-50 [16110086950]

AZELEX CREAM

• Marketing Category: NDA
• Application Number: NDA020428
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-07-12

Drug Details

Active Ingredients

Ingredient	Strength
AZELAIC ACID	.2 g/g

OpenFDA Data

• SPL SET ID: ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75
• Manufacturer:
  • Almirall, LLC
• UNII:
  • F2VW3D43YT
• RxNorm Concept Unique ID - RxCUI:
  • 1043753
  • 1041520

Pharmacological Class

• Decreased Protein Synthesis [PE]
• Decreased Sebaceous Gland Activity [PE]
• Decreased Protein Synthesis [PE]
• Decreased Sebaceous Gland Activity [PE]

NDC Crossover Matching brand name "AZELEX" or generic name "Azelaic Acid"

NDC	Brand Name	Generic Name
0023-8694	AZELEX	azelaic acid
16110-869	AZELEX	azelaic acid
0115-1624	Azelaic Acid	Azelaic Acid
0591-2131	azelaic acid	azelaic acid
51672-1389	Azelaic Acid	Azelaic Acid
68462-626	azelaic acid	azelaic acid
0781-7172	Azelaic Acid Gel	azelaic acid
10922-825	Finacea	azelaic acid
10922-826	Finacea	azelaic acid
50090-3032	Finacea	azelaic acid
50090-4473	Finacea	azelaic acid
50222-505	Finacea	azelaic acid
50419-825	Finacea	azelaic acid
50222-303	FINACEA FOAM	azelaic acid
50419-829	FINACEA FOAM	azelaic acid