Label: AK-POLY-BAC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 17478-238-35
- Packager: Akorn
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 8, 2020
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- SPL UNCLASSIFIED SECTION
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a sterile antimicrobial ointment for ophthalmic use.
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is:
Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:
Each gram contains: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.
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INGREDIENTS AND APPEARANCE
bacitracin zinc and polymyxin b sulfate ointment
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-238 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [USP'U] in 1 g Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength Mineral Oil (UNII: T5L8T28FGP) Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17478-238-35 1 in 1 CARTON 05/08/2006 1 3.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064028 05/08/2006 Labeler - Akorn (117696770) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696840 MANUFACTURE(17478-238) , ANALYSIS(17478-238) , STERILIZE(17478-238) , PACK(17478-238) , LABEL(17478-238)