NDC 16110-518

Altabax

Retapamulin

Altabax is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Aqua Pharmaceuticals, Llc. The primary component is Retapamulin.

• Product ID: 16110-518_1baa5940-b284-4487-8103-deb4c8430641
• NDC: 16110-518
• Product Type: Human Prescription Drug
• Proprietary Name: Altabax
• Generic Name: Retapamulin
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA022055
• Labeler Name: Aqua Pharmaceuticals, LLC
• Substance Name: RETAPAMULIN
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Diterpenes [CS],Pleuromutilin Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 16110-518-15

1 TUBE in 1 CARTON (16110-518-15) > 15 g in 1 TUBE

• Marketing Start Date: 2016-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16110-518-15 [16110051815]

Altabax OINTMENT

• Marketing Category: NDA
• Application Number: NDA022055
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-05-01

NDC 16110-518-30 [16110051830]

Altabax OINTMENT

• Marketing Category: NDA
• Application Number: NDA022055
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-05-01

Drug Details

Active Ingredients

Ingredient	Strength
RETAPAMULIN	10 mg/g

OpenFDA Data

• SPL SET ID: 7c91eee4-242b-4af2-a39b-7842a9d95143
• Manufacturer:
  • Aqua Pharmaceuticals, LLC
• UNII:
  • 4MG6O8991R
• RxNorm Concept Unique ID - RxCUI:
  • 704855
  • 704858

Pharmacological Class

• Diterpenes [CS]
• Pleuromutilin Antibacterial [EPC]

NDC Crossover Matching brand name "Altabax" or generic name "Retapamulin"

NDC	Brand Name	Generic Name
16110-518	Altabax	retapamulin
21695-644	Altabax	retapamulin