NDC 61010-5603

Triple Antibiotic

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

Triple Antibiotic is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Safetec Of America, Inc.. The primary component is Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate.

Product ID61010-5603_6572391c-6be6-4b00-978c-74e926c8f71c
NDC61010-5603
Product TypeHuman Otc Drug
Proprietary NameTriple Antibiotic
Generic NameBacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2007-03-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333B
Labeler NameSafetec of America, Inc.
Substance NameBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active Ingredient Strength400 [iU]/g; mg/g; [iU]/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 61010-5603-4

144 POUCH in 1 BOX (61010-5603-4) > .5 g in 1 POUCH (61010-5603-2)
Marketing Start Date2007-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61010-5603-2 [61010560302]

Triple Antibiotic OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart333B
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-03-30

NDC 61010-5603-4 [61010560304]

Triple Antibiotic OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart333B
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-03-30
Inactivation Date2020-01-31
Reactivation Date2020-03-24

Drug Details

Active Ingredients

IngredientStrength
BACITRACIN ZINC400 [iU]/g

OpenFDA Data

SPL SET ID:2c2aa8af-2adb-4f59-ac20-15818d0e28e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204602

    • NDC Crossover Matching brand name "Triple Antibiotic" or generic name "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate"

    NDCBrand NameGeneric Name
    0168-0012Triple AntibioticNeomycin and Polymyxin B Sulfates and Bacitracin Zinc
    0363-0179Triple AntibioticBacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate
    0363-0539triple antibioticbacitracin zinc, neomycin, polymyxin B
    0363-2900Triple AntibioticBacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate, Pramoxine hydrochloride
    0363-8888Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride
    0472-0179Triple AntibioticBacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
    0498-0750Triple AntibioticBacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate
    0713-0268Triple AntibioticPolymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate
    0904-0734TRIPLE ANTIBIOTICBacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
    0924-5603triple antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate
    0924-5610Triple AntibioticBacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
    11822-0073triple antibioticbacitracin zinc, neomycin, polymyxin B
    11822-2700Triple AntibioticBacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate, Pramoxine hydrochloride
    11822-2900Triple AntibioticBacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate
    15127-122Triple AntibioticBacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
    67777-118Triple AntibioticTriple Antibiotic
    68016-120Triple AntibioticTriple Antibiotic
    68071-3378TRIPLE ANTIBIOTICTRIPLE ANTIBIOTIC
    68788-6351triple antibiotictriple antibiotic
    68788-9811TRIPLE ANTIBIOTICTRIPLE ANTIBIOTIC
    69103-5005Triple AntibioticTriple Antibiotic
    69396-015Triple AntibioticTriple Antibiotic
    69396-002Triple AntibioticTriple Antibiotic
    70677-0013Triple AntibioticTriple Antibiotic
    71205-006TRIPLE ANTIBIOTICTRIPLE ANTIBIOTIC
    71141-134Triple AntibioticTriple Antibiotic
    71927-003Triple AntibioticTriple Antibiotic
    72570-107Triple AntibioticTriple Antibiotic
    21695-194Triple AntibioticTriple Antibiotic
    30142-037Triple AntibioticTriple Antibiotic
    36800-564Triple AntibioticTriple Antibiotic
    37808-263Triple AntibioticTriple Antibiotic
    41250-067triple antibiotictriple antibiotic
    41415-120Triple AntibioticTriple Antibiotic
    41250-433triple antibiotictriple antibiotic
    41250-719Triple AntibioticTriple Antibiotic
    45802-143triple antibiotictriple antibiotic
    47682-223Triple AntibioticTriple Antibiotic
    45865-640Triple AntibioticTriple Antibiotic
    46122-414Triple AntibioticTriple Antibiotic
    47682-392Triple AntibioticTriple Antibiotic
    47682-934Triple AntibioticTriple Antibiotic
    49035-016Triple AntibioticTriple Antibiotic
    49035-120Triple AntibioticTriple Antibiotic
    50090-1859triple antibiotictriple antibiotic
    50382-023Triple AntibioticTriple Antibiotic
    50607-5600Triple AntibioticTriple Antibiotic
    51672-2016Triple AntibioticTriple Antibiotic
    51824-006Triple AntibioticTriple Antibiotic
    51672-2120Triple AntibioticTriple Antibiotic
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.