NDC 21695-644

Altabax

Retapamulin

Altabax is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Retapamulin.

Product ID21695-644_5da8f60f-c809-4161-a802-6fe823d532bb
NDC21695-644
Product TypeHuman Prescription Drug
Proprietary NameAltabax
Generic NameRetapamulin
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2010-01-07
Marketing CategoryNDA / NDA
Application NumberNDA022055
Labeler NameRebel Distributors Corp.
Substance NameRETAPAMULIN
Active Ingredient Strength10 mg/g
Pharm ClassesDiterpenes [CS],Pleuromutilin Antibacterial [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-644-10

10 g in 1 TUBE (21695-644-10)
Marketing Start Date2010-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-644-10 [21695064410]

Altabax OINTMENT
Marketing CategoryNDA
Application NumberNDA022055
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2010-01-07
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
RETAPAMULIN10 mg/g

Pharmacological Class

  • Diterpenes [CS]
  • Pleuromutilin Antibacterial [EPC]

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

NDCBrand NameGeneric Name
16110-518Altabaxretapamulin
21695-644Altabaxretapamulin

Trademark Results [Altabax]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALTABAX
ALTABAX
78618953 3330992 Live/Registered
ALMIRALL, S.A.
2005-04-28

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