HomeNDC LookupIngredientsIpratropium Bromide › 72162-2143-03
Ipratropium Bromide 21 ug Spray — NDC 72162-2143-03 package photo

Ipratropium Bromide 21 ug Spray

by Bryant Ranch Prepack · 1 BOTTLE, SPRAY in 1 CARTON (72162-2143-3) / 345 SPRAY in 1 BOTTLE, SPRAY
NDC 72162-2143-03
🏷️ FDA NDC (as labeled) 72162-2143-3 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 72162-2143-3
Product NDC 72162-2143
11-digit billing NDC 72162214303
NCPDP billing unit ML — per mL (volume)
RxCUI 1797833
UNII J697UZ2A9J
Application # ANDA076664
SPL Set ID fcf20db7-091d-40de-8755-03773fc47edd
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-11-05
Route NASAL
Dosage form SPRAY
Substance IPRATROPIUM BROMIDE
GCN Seq No 024457
GCN 42239
HICL code 000057
Ingredient (HICL) Ipratropium Bromide
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7A
Therapeutic class — specific (HIC3) Nose Preparations, Miscellaneous (Rx)
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name IPRATROPIUM 0.03% SPRAY
FDB brand name Ipratropium Bromide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72162-2143-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 72162-2143-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic
Drug family (ATC) Other nasal preparations, Anticholinergics
How it works Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA076664 (ANDA)
Labeler code72162
First marketedNov 2003
Product typeHuman Prescription Drug
Portfolio4,434 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name IPRATROPIUM 0.03% SPRAY Ingredient Ipratropium Bromide
📖 What it is MedlinePlus · NLM

Ipratropium nasal spray is available in two strengths that are used to treat different conditions. Ipratropium nasal spray 0.06% is used to relieve a runny nose caused by the common cold or seasonal allergies (hay fever) in adults and children age 5 and older. Ipratropium nasal spray 0.03% is used to relieve a runny nose caused by year-round allergic and nonallergic rhinitis (runny nose and stuffiness) in adults and children age 6 and older. Ipratropium nasal spray does not relieve nasal congestion, sneezing, or postnasal drip caused by these conditions. Ipratropium nasal spray is in a class o...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the form you were prescribed. The inhaler (like Atrovent HFA) and the nebulizer solution are used every day to help keep the airways open if you have COPD — condition...
  • What is ipratropium actually used for — is it for my COPD or my runny nose?
  • No — the inhaler is a maintenance medication, meaning it's meant to be used on a regular schedule to prevent breathing problems, not to rescue you during a sudden flare-up. If you'...
  • Can I use my ipratropium inhaler during a sudden asthma or COPD attack when I can't breathe?
📖 Read our full Ipratropium guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 25IH6R4SGF
    Edetate calcium disodium is a chelating agent, a chemical that binds to metal ions. It's used in some medications to prevent unwanted metals from interfering with the drug's stability and effectiveness.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 8136Y38GY5
    A plant-derived thickening agent made from cellulose. It increases the thickness and consistency of liquid medicines, helping them coat surfaces and flow smoothly.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.6490
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ipratropium Bromide 21 ug 00054-0045-44 Hikma 1 bottle $0.355 AB Availability likely
Ipratropium Bromide 21 ug 16714-0526-01 NORTHSTAR 1 bottle $0.355 AB Availability likely
Ipratropium Bromide 21 ug 60505-0826-01 Apotex 1 bottle $0.355 AB Availability likely
Ipratropium Bromide 21 ug 69238-2016-03 Amneal 1 bottle $0.355 AB Availability likely
Ipratropium Bromide 21 ug 70748-0336-01 Lupin 1 bottle $0.355 AB Availability likely
Ipratropium Bromide 21 ug 72888-0149-38 Advagen 1 bottle $0.355 AB Availability likely
Ipratropium bromide 21 ug 24208-0398-30 Bausch 1 bottle $0.420 AB FDA listed
Ipratroprium Bromide 21 ug 68682-0398-30 Oceanside 1 bottle AB FDA listed
Ipratropium Bromide 21 ugthis 72162-2143-03 Bryant 1 bottle AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2003
On the market since
Nov 2003
📍
2026
Currently FDA-listed
23 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ipratropium Bromide — the program that covers self-administered drugs. 13 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ipratropium Bromide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.15M
Claims incl. refills
666.7K
Beneficiaries
481.7K
Spend / beneficiary
$39.75
Spend / claim
$28.72
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ipratropium Bromide — the ingredient across all brands.

Top reported reactions

Dyspnoea6,721
Asthma4,204
Pneumonia3,446
Cough3,300
Wheezing2,775
Fatigue2,488
Nausea2,200

Age at onset

Neonate17
Infant36
Child135
Adolescent91
Adult2,880
Elderly3,373

Reporter sex

39,628 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization16,882
Death5,048
Life-threatening2,321
Disabling1,140
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,106 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72162-2143-03 You're viewing this 1 BOTTLE, SPRAY in 1 CARTON (72162-2143-3) / 345 SPRAY in 1 BOTTLE, SPRAY 2023-12-07 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72162-2143-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72162-2143-03, written without dashes as 72162214303. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72162-2143-03, the first segment (72162) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2143) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📦 How Supplied / Storage and Handling 133 words

HOW SUPPLIED Ipratropium Bromide Nasal Solution, 0.03% is supplied as a clear, colorless solution in a white high density polyethylene (HDPE) bottle fitted with a white and clear metered nasal spray pump, a green safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 31.1 g of product formulation, 345 sprays, each delivering 21 mcg (70 mcL) of ipratropium per spray, or 28 days of therapy at the maximum recommended dose (two sprays per nostril three times a day). Ipratropium Bromide Nasal Solution, 0.03% Nasal Spray, 21 mcg/spray NDC 72162-2143-03 : Bottle of 30 mL (345 metered sprays) Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid freezing.

Keep out of reach of children. Do not spray in the eyes.

💬 Information for Patients ~3 min read

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 cong…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.