HomeNDC LookupIngredientsIpratropium Bromide › 00054-0045-44
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Ipratropium Bromide 21 ug Spray

by Hikma Pharmaceuticals USA Inc. · 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) / 345 SPRAY in 1 BOTTLE, SPRAY
NDC 00054-0045-44
🏷️ FDA NDC (as labeled) 0054-0045-44 billing pads the labeler 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) 0054-0045-44
Product NDC 0054-0045
11-digit billing NDC 00054004544
NCPDP billing unit ML — per mL (volume)
RxCUI 1797833
UNII J697UZ2A9J
Application # ANDA076664
SPL Set ID 05c56190-e346-4674-a4f8-049ce632ce2d
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
GPI-14 42300040102010
GPI class 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 0054-0045-44 — a 4-4-2 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 labeler segment → 00054-0045-44. 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA076664 (ANDA)
Labeler code00054
First marketedNov 2003
Product typeHuman Prescription Drug
Portfolio726 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
📗 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 $0.355
Medicaid paysCMS SDUD · 12 mo $0.7995
Medicare drug plans payPart D · Q2 2026 $0.6490
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.881 $0.349
▼ Down 50% over the last 24 months.
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 ugthis 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 +18%
Ipratroprium Bromide 21 ug 68682-0398-30 Oceanside 1 bottle AB FDA listed
Ipratropium Bromide 21 ug 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00054-0045-44, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
28.4K
Units reimbursed last 4 qtrs
854.2K
Gross reimbursed last 4 qtrs
$682.9K
Avg / prescription
$24.03
Avg / unit
$0.7995
Latest quarter Q1 2026
8.5KRx
Medicaid pays / mL
$0.7995
gross reimbursed
vs
NADAC / mL
$0.3548
acquisition cost
=
Spread
+$0.4447
+125% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
40% FFS 60% MCO
Fee-for-service · 11,227 Rx Managed care · 17,187 Rx
State Medicaid map
Alaska: 2,610 units · 356 per 100k residents AK Maine: no data reported ME Washington: 17,340 units · 222 per 100k residents WA Idaho: 4,980 units · 254 per 100k residents ID Montana: 930 units · 82.2 per 100k residents MT North Dakota: no data reported ND Minnesota: 17,130 units · 299 per 100k residents MN Wisconsin: 23,670 units · 401 per 100k residents WI Michigan: 60,392 units · 602 per 100k residents MI New York: 80,520 units · 411 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 5,910 units · 140 per 100k residents OR Nevada: 17,820 units · 558 per 100k residents NV Wyoming: 390 units · 66.8 per 100k residents WY South Dakota: no data reported SD Iowa: 7,890 units · 246 per 100k residents IA Illinois: 5,400 units · 43.0 per 100k residents IL Indiana: 19,051 units · 278 per 100k residents IN Ohio: 52,800 units · 448 per 100k residents OH Pennsylvania: 24,480 units · 189 per 100k residents PA New Jersey: 14,759 units · 159 per 100k residents NJ Massachusetts: 11,612 units · 166 per 100k residents MA California: 86,250 units · 221 per 100k residents CA Utah: 5,520 units · 162 per 100k residents UT Colorado: 36,780 units · 626 per 100k residents CO Nebraska: 4,800 units · 243 per 100k residents NE Missouri: 10,860 units · 175 per 100k residents MO Kentucky: 49,111 units · 1,085 per 100k residents KY West Virginia: 9,930 units · 561 per 100k residents WV Virginia: 6,480 units · 74.3 per 100k residents VA Maryland: 17,764 units · 287 per 100k residents MD Connecticut: 6,900 units · 191 per 100k residents CT Rhode Island: 3,240 units · 296 per 100k residents RI Arizona: 29,490 units · 397 per 100k residents AZ New Mexico: 23,280 units · 1,101 per 100k residents NM Kansas: 2,490 units · 84.7 per 100k residents KS Arkansas: 15,870 units · 517 per 100k residents AR Tennessee: 23,160 units · 325 per 100k residents TN North Carolina: 35,580 units · 328 per 100k residents NC South Carolina: 3,150 units · 58.6 per 100k residents SC Delaware: 3,270 units · 317 per 100k residents DE Oklahoma: 6,690 units · 165 per 100k residents OK Louisiana: 40,800 units · 892 per 100k residents LA Mississippi: 13,605 units · 463 per 100k residents MS Alabama: 2,640 units · 51.7 per 100k residents AL Georgia: 18,465 units · 167 per 100k residents GA D.C.: no data reported DC Hawaii: 1,260 units · 87.8 per 100k residents HI Texas: 23,580 units · 77.3 per 100k residents TX Florida: 3,060 units · 13.5 per 100k residents FL
Units reimbursed · per 100k residents
13.51,101
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Mexico 1,101 /100k
2 Kentucky 1,085 /100k
3 Louisiana 892 /100k
4 Colorado 626 /100k
5 Michigan 602 /100k
6 West Virginia 561 /100k
7 Nevada 558 /100k
8 Arkansas 517 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 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
00054-0045-44 You're viewing this 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) / 345 SPRAY in 1 BOTTLE, SPRAY 2003-11-05 Active

📄 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.
💬 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.