Neomycin And Polymyxin B Sulfates And Bacitracin Zinc
Rising Pharma Holdings, Inc.
Human Prescription Drug
NDC 16571-754Neomycin And Polymyxin B Sulfates And Bacitracin Zinc is a human prescription drug labeled by 'Rising Pharma Holdings, Inc.'. National Drug Code (NDC) number for Neomycin And Polymyxin B Sulfates And Bacitracin Zinc is 16571-754. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Neomycin And Polymyxin B Sulfates And Bacitracin Zinc drug includes Bacitracin Zinc - 400 [USP'U]/g Neomycin Sulfate - 3.5 mg/g Polymyxin B Sulfate - 10000 [USP'U]/g . The currest status of Neomycin And Polymyxin B Sulfates And Bacitracin Zinc drug is Active.
Drug Information:
| Drug NDC: | 16571-754 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Neomycin And Polymyxin B Sulfates And Bacitracin Zinc |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Neomycin And Polymyxin B Sulfates And Bacitracin Zinc |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rising Pharma Holdings, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | BACITRACIN ZINC - 400 [USP'U]/g
NEOMYCIN SULFATE - 3.5 mg/g
POLYMYXIN B SULFATE - 10000 [USP'U]/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA AUTHORIZED GENERIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 07 Apr, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA050417 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Rising Pharma Holdings, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308493
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0316571754533
|
| UPC stands for Universal Product Code. |
| UNII: | 89Y4M234ES
057Y626693
19371312D4
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Aminoglycoside Antibacterial [EPC]
Aminoglycosides [CS]
Decreased Cell Wall Synthesis & Repair [PE]
Polymyxin-class Antibacterial [EPC]
Polymyxins [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 16571-754-53 | 1 TUBE in 1 CARTON (16571-754-53) / 3.5 g in 1 TUBE | 01 Nov, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Neomycin and polymyxin b sulfates and bacitracin zinc neomycin and polymyxin b sulfates and bacitracin zinc neomycin sulfate neomycin polymyxin b sulfate polymyxin b bacitracin zinc bacitracin petrolatum
Indications and Usage:
Indications & usage neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Warnings:
Warnings not for injection into the eye. neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. ophthalmic ointments may retard corneal wound healing. topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. a precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. the manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. a sensitization reaction may manifest simply as a failure to heal. during long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. symptoms usually subside quickly on withdrawing the medication. application of products containing these ingredients should be avoided for the patient thereafter ( see precau
Read more...tions: general ).
Dosage and Administration:
Dosage & administration apply the ointment topically into the conjunctival sac of the affected eye(s) every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
Contraindications:
Contraindications neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.
Adverse Reactions:
Adverse reactions adverse reactions have occurred with the anti-infective components of neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment. the exact incidence is not known. reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema ( see warnings ). more serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. local irritation on instillation has also been reported. to report suspected adverse reactions, contact rising pharma holdings, inc. at (1-844-874-7464) or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Use in Pregnancy:
Pregnancy teratogenic effects: animal reproduction studies have not been conducted with neomycin sulfate, polymyxin b sulfate, or bacitracin. it is also not known whether neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in children have not been established.
Geriatric Use:
Geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description:
Description neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment, usp is a sterile antimicrobial ointment for topical ophthalmic use. each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin b sulfate equivalent to 10,000 polymyxin b units, and bacitracin zinc equivalent to 400 bacitracin units and petrolatum q.s. neomycin sulfate is the sulfate salt of neomycin b and c, which are produced by the growth of streptomyces fradiae waksman (fam. streptomycetaceae). it has a potency equivalent of not less than 600 micrograms of neomycin standard per mg, calculated on an anhydrous basis. the structural formulae are: polymyxin b sulfate is the sulfate salt of polymyxin b 1 and b 2 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: 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 is: image-1 image-2 image-3
Clinical Pharmacology:
Clinical pharmacology a wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin b sulfate, and bacitracin. neomycin is bactericidal for many gram-positive and gram-negative organisms. it is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal rna and causing misreading of the bacterial genetic code. polymyxin b is bactericidal for a variety of gram-negative organisms. it increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane. bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. it interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis. microbiology neomycin sulfate, polymyxin b sulfate and bacitracin zinc together are considered active against the following microorganisms: staphylococcus aureus , streptococci including strepto
Read more...coccus pneumoniae, escherichia coli, haemophilus influenzae, klebsiella/enterobacter species, neisseria species, and pseudomonas aeruginosa . the product does not provide adequate coverage against serratia marcescens .
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis & mutagenesis & impairment of fertility long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin b sulfate or bacitracin. treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/ml) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. polymyxin b has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. no adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.
How Supplied:
How supplied neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment, usp is supplied in a tube of 1/8 oz (3.5 g) with an ophthalmic tip (ndc 16571-754-53). caution: federal law prohibits dispensing without a prescription. store at 15°c to 25°c (59°f to 77°f). for topical ophthalmic use distributed by: rising pharma holdings, inc. east brunswick, nj 08816 issued: 02/2021 pia75453-00 made in canada
Information for Patients:
Information for patients patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. the use of this product by more than one person may spread infection. patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. serious damage to the eye and subsequent loss of vision may result from using contaminated products ( see precautions: general ). if the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. do not use this product if you are allergic to any of the listed ingredients. keep tightly closed when not in use. keep out of reach of children.
Package Label Principal Display Panel:
Package label.principal display panel rising® ndc 16571-754-53 neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment, usp net wt. 1/8 oz. (3.5g) sterile rx only carton