Ipratropium Bromide


West-ward Pharmaceuticals Corp.
Human Prescription Drug
NDC 0054-0045
Ipratropium Bromide is a human prescription drug labeled by 'West-ward Pharmaceuticals Corp.'. National Drug Code (NDC) number for Ipratropium Bromide is 0054-0045. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Ipratropium Bromide drug includes Ipratropium Bromide - 21 ug/1 . The currest status of Ipratropium Bromide drug is Active.

Drug Information:

Drug NDC: 0054-0045
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: Ipratropium Bromide
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: Ipratropium Bromide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: West-ward Pharmaceuticals Corp.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Spray
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:IPRATROPIUM BROMIDE - 21 ug/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:NASAL
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: ANDA
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: 05 Nov, 2003
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 19 Dec, 2025
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: ANDA076664
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, 2024
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:West-Ward Pharmaceuticals Corp.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1797833
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.
UNII:J697UZ2A9J
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:Anticholinergic [EPC]
Cholinergic Antagonists [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0054-0045-441 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) / 345 SPRAY in 1 BOTTLE, SPRAY05 Nov, 2003N/ANo
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:

Ipratropium bromide ipratropium bromide benzalkonium chloride edetate calcium disodium hydrochloric acid water sodium chloride sodium hydroxide hydroxyethyl cellulose (140 mpa.s at 5%) ipratropium bromide ipratropium ipratropium bromide anhydrous

Information for Patients:

Patient’s instructions for use ipratropium bromide nasal solution, 0.03% nasal spray, 21mcg/spray read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening. ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. read complete instructions carefully and use only as directed. to use: 1. remove the clear plastic dust cap and the green safety clip from the nasal spray pump ( figure 1 ). the safety clip prevents the accidental discharge of the spray in your pocket or purse. figure 1 figure 1 2. the nasal spray pump must be primed before ipratropium bromide nasal solution, 0.03% is used
for the first time. to prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. make sure the bottle points upright and away from your eyes. press your thumb firmly and quickly against the bottle seven times ( figure 2 ). the pump is now primed and can be used. your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require two sprays. if you have not used your nasal spray for more than seven days, repriming the pump will require seven sprays. figure 2 figure 2 3. before using ipratropium bromide nasal solution, 0.03%, blow your nose gently to clear your nostrils if necessary. 4. close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril ( figure 3 ). point the tip toward the back and outer side of the nose. figure 3 figure 3 5. press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. following each spray, sniff deeply and breathe out through your mouth. 6. after spraying the nostril and removing the unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose. 7. repeat steps 4 through 6 in the same nostril. 8. repeat steps 4 through 7 in the other nostril (i.e., two sprays per nostril). 9. replace the clear plastic dust cap and safety clip. 10. at some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. you should not take extra doses or stop using ipratropium bromide nasal solution, 0.03% without consulting your physician. to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water ( figure 4 ) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. figure 4 figure 4 caution: ipratropium bromide nasal solution, 0.03% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution, 0.03% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent during the first full day of treatment with ipratropium bromide nasal solution, 0.03% some patients may require up to two weeks of treatment to obtain maximum benefit. do not spray ipratropium bromide nasal solution, 0.03% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution, 0.03% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid freezing. keep out of reach of children. address medical inquiries to hikma pharmaceuticals usa inc. at 1-800-962-8364. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000619/01 revised july 2022 figure-1.jpg figure-2.jpg figure-3.jpg figure-4.jpg

Package Label Principal Display Panel:

Package/label principal display panel ndc 0054- 0045 -44 30 ml (345 metered sprays) ipratropium bromide nasal solution / nasal spray 0.03% 21 mcg/spray rx only 0.03% bottle label

Package/label principal display panel ndc 0054- 0045 -44 30 ml (345 metered sprays) ipratropium bromide nasal solution 0.03% nasal spray 21 mcg/spray rx only 0.03% folding carton


Comments/ Reviews:

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