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NDC 17478-0238-35 AK-POLY-BAC 500; 10000 [USP'U]/g; [USP'U]/g Details

AK-POLY-BAC 500; 10000 [USP'U]/g; [USP'U]/g

AK-POLY-BAC is a OPHTHALMIC OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Akorn. The primary component is BACITRACIN ZINC; POLYMYXIN B SULFATE.

Product Information

NDC	17478-0238
Product ID	17478-238_f764e0be-a828-4f44-9c91-86326a152f48
Associated GPIs	86109902104200
GCN Sequence Number	059718
GCN Sequence Number Description	bacitracin/polymyxin B sulfate OINT. (G) 500-10K/G OPHTHALMIC
HIC3	Q6W
HIC3 Description	OPHTHALMIC ANTIBIOTICS
GCN	25486
HICL Sequence Number	003383
HICL Sequence Number Description	BACITRACIN/POLYMYXIN B SULFATE
Brand/Generic	Generic
Proprietary Name	AK-POLY-BAC
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc and Polymyxin B Sulfate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	500; 10000
Active Ingredient Units	[USP'U]/g; [USP'U]/g
Substance Name	BACITRACIN ZINC; POLYMYXIN B SULFATE
Labeler Name	Akorn
Pharmaceutical Class	Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA064028
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17478-0238-35 (17478023835)

Pricing Information
NDC Package Code	17478-238-35
Billing NDC	17478023835
Package	1 TUBE in 1 CARTON (17478-238-35) / 3.5 g in 1 TUBE
Marketing Start Date	2006-05-08
NDC Exclude Flag	N
Price Per Unit	3.09351
Pricing Unit	GM
Effective Date	2022-11-23
NDC Description	AK-POLY-BAC EYE OINTMENT
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 8b750666-18f2-40f5-9fb3-87457001b485 Details

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION:

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.

CLINICAL PHARMACOLOGY:

Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

INDICATIONS AND USAGE:

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

CONTRAINDICATIONS:

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

WARNINGS:

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS:

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.

DOSAGE AND ADMINISTRATION:

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

HOW SUPPLIED:

Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.

NDC 17478-238-35

STORAGE:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Akorn

Manufactured By: Akorn, Inc.

Lake Forest, IL 60045

AKP00N

Rev. 06/16

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-238-35 Akorn

AK-POLY-BAC™

brand of Bacitracin Zinc and Polymyxin B Sulfate

Ophthalmic Ointment USP

For Ophthalmic Use Only. Sterile

Rx only Net Wt 3.5 g (1/8 oz)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-238-35

AK-POLY-BAC™

brand of Bacitracin Zinc and Polymyxin B Sulfate

Ophthalmic Ointment, USP

Net Wt 3.5 g (1/8 oz.) Sterile Rx only Akorn Logo

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

AK-POLY-BAC

bacitracin zinc and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:17478-238
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
Mineral Oil (UNII: T5L8T28FGP)
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA064028	05/08/2006

Labeler - Akorn (117696770)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(17478-238) , ANALYSIS(17478-238) , STERILIZE(17478-238) , PACK(17478-238) , LABEL(17478-238)

Revised: 10/2020

Document Id: f764e0be-a828-4f44-9c91-86326a152f48

Set id: 8b750666-18f2-40f5-9fb3-87457001b485

Version: 6

Effective Time: 20201008

Search by Drug Name or NDC

NDC 17478-0238-35 AK-POLY-BAC 500; 10000 [USP'U]/g; [USP'U]/g Details

AK-POLY-BAC 500; 10000 [USP'U]/g; [USP'U]/g

Product Information

Package

Package Images

NDC 17478-0238-35 (17478023835)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8b750666-18f2-40f5-9fb3-87457001b485 Details

SPL UNCLASSIFIED SECTION

DESCRIPTION:

CLINICAL PHARMACOLOGY:

INDICATIONS AND USAGE:

CONTRAINDICATIONS:

WARNINGS:

PRECAUTIONS:

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED:

STORAGE:

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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