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Cromolyn Sodium 20 mg/2mL Inhalant — NDC 42571-350-09 (Billing 42571-0350-09)

by Micro Labs Limited · 5 CARTON in 1 CARTON / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE

This is a package of Cromolyn Sodium 20 mg/2mL Inhalant from Micro Labs Limited, no longer marketed (first marketed Jun 2022), no longer in the FDA NDC Directory; retail pharmacies pay about $0.9626 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 42571-0350-09
🏷️ FDA NDC (as labeled) 42571-350-09 billing pads the product segment with a zero
This package
Contains2 mL in 1 ampule Cost per mL$0.9626 NADAC Per package$115.51 / 120 ml Pack sizes2 compare ↓
Also priced by: Part D plans $1.86/unit — full pricing hub ↓
Main listing for product 42571-350 · Also comes in: 12 ampules 42571-350-50
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 42571-350-09 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
42571 labeler · 350 product · 09 package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0342571350086
FDA record last changed
Aug 6, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42571-350-09
Product NDC 42571-350
11-digit billing NDC 42571035009
NCPDP billing unit ML — per mL (volume)
RxCUI 831246
UNII Q2WXR1I0PK
UPC 0342571350086
Application # ANDA213658
SPL Set ID aebec664-ed80-447c-9789-0cf47c8b7429
Established class (EPC) Mast Cell Stabilizer
Physiologic effect Decreased Histamine Release
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2022-06-01
Route INTRABRONCHIAL
Dosage form INHALANT
Substance CROMOLYN SODIUM
TE code (Orange Book) AN · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 44150010102505
GPI class Cromolyn Sodium
GCN Seq No 011688
GCN 46780
HICL code 004526
Ingredient (HICL) Cromolyn Sodium
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z21
Therapeutic class — specific (HIC3) Mast Cell Stabilizers, Orally Inhaled
AHFS code 48:10.32.00
AHFS class Mast-Cell Stabilizers
FDB label name CROMOLYN 20 MG/2 ML NEB SOLN
FDB brand name Cromolyn Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011688
  • GCN: 46780
  • GPI-14 (Medi-Span): 44150010102505
  • HICL (First Databank): 004526
  • AHFS class code: 48:10.32.00
  • RxCUI (RxNorm): 831246
Why two NDCs? The FDA registers this code as 42571-350-09 — a 5-3-2 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 product segment → 42571-0350-09. 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 Mast Cell Stabilizer class.

Pharmacologic class Mast Cell Stabilizer
Drug family (ATC) Antiallergic agents, excl. corticosteroids, Agents for dermatitis, excluding corticosteroids, Antiallergic agents, excl. corticosteroids
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.

Clinical

Label name CROMOLYN 20 MG/2 ML NEB SOLN Ingredient Cromolyn Sodium
📖 What it is MedlinePlus · NLM

Cromolyn oral inhalation is used to prevent the wheezing, shortness of breath, difficulty breathing, coughing, and chest tightness caused by asthma. It also is used to prevent breathing difficulties (bronchospasm) caused by exercise, cold and dry air, or by inhaling substances such as pet dander, pollen, dust mites, or chemicals, such as perfume. It works by preventing the release of substances that cause inflammation (swelling) in the air passages of the lungs.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No — and this is really important to understand. Cromolyn sodium is a preventive medicine only. It does not open your airways once they've tightened up. You should always have a se...
  • Will this inhaler stop an asthma attack if I'm already having one?
  • It can take several weeks of regular use before you feel the full benefit — though some people notice improvement sooner. The key is consistency. Taking it at the same times every...
  • How long does it take before I notice it working?
📖 Read our full Cromolyn Oral Inhalation 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.

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 $0.963 $115.51 / 120 ml
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 $1.86 $222.70 / 120 ml
Medicare Part B allowsASP · J7631 $0.691 / J7631 unit —
NADAC price history (per mL) — tap or hover for the price & month
Jun 2023 Feb 2026 May 2026 Sep 2026 $1.496 $0.566
▼ Down 36% over the last 11 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.

Billing & reimbursement

FDA NDC (as labeled)42571-350-09
11-digit billing NDC42571-0350-09
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7631
DescriptorCROMOLYN SODIUM, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
Billing units / pkg1 units
How the units are derivedThis package is 2 ML; the HCPCS unit is 10 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$27,578 · 175 claims · $157.59 per claim (all NDCs under J7631)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
42571-0350-09 You're viewing this Main listing 5 CARTON in 1 CARTON / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE $0.9626 / mL $115.51 2022-06-01 — Discontinued by firm
42571-0350-50 42571-350-50 10 CARTON in 1 CARTON / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE — — 2022-06-01 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 carton in 1 carton / 12 ampule in 1 carton / 2 ml in 1 ampule.
What NDC number is used to bill for this package of Cromolyn Sodium 20 mg/2mL Inhalant?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cromolyn Sodium 20 mg/2mL 00172-6406-49 Teva 12 pouches $0.963 AN Availability likely —
Cromolyn Sodium 20 mg/2mLthis 42571-0350-09 Micro 12 ampules $0.963 AN Discontinued —
Cromolyn Sodium Inhalation Solution 20 mg/2mL 76204-0028-60 Ritedose 2 pouches $0.963 AN Discontinued —
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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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.

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.

🧪 Avoiding an ingredient? See Cromolyn Oral Inhalation inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerMicro Labs Limited
Application holderMICRO LABS LTD
FDA applicationANDA213658 (ANDA)
Labeler code42571
First marketedJun 2022
Product typeHuman Prescription Drug
Portfolio190 products on file

More NDCs from Micro Labs Limited labeler code 42571

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 113 words ▾

INDICATIONS AND USAGE Cromolyn sodium inhalation solution, USP is a prophylactic agent indicated in the management of patients with bronchial asthma. In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution, USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ). The effect of cromolyn sodium inhalation solution is usually evident after several weeks of treatment, although some patients show an almost immediate response.

In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium inhalation solution should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION For management of bronchial asthma in adults and pediatric patients (two years of age and over), the usual starting dosage is the contents of one ampule administered by nebulization four times a day at regular intervals. Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established. Patients with chronic asthma should be advised that the effect of cromolyn sodium inhalation solution therapy is dependent upon its administration at regular intervals, as directed.

Cromolyn sodium inhalation solution should be introduced into the patient's therapeutic regimen when the acute episode has been controlled, the airway has been cleared and the patient is able to inhale adequately. For the prevention of acute bronchospasm which follows exercise or exposure to cold dry air, environmental agents ( e.g. , animal danders, toluene diisocyanate, pollutants), etc., the usual dose is the contents of one ampule administered by nebulization shortly before exposure to the precipitating factor. It should be emphasized to the patient that the drug is poorly absorbed when swallowed and is not effective by this route of administration.

For additional information, see the accompanying leaflet entitled “ Living a Full Life with Asthma” . Cromolyn sodium inhalation solution Therapy in Relation to Other Treatments for Asthma: Non-steroidal agents Cromolyn sodium inhalation solution should be added to the patient's existing treatment regimen ( e.g. , bronchodilators). When a clinical response to cromolyn sodium inhalation solution is evident, usually within two to four weeks, and if the asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually.

If concomitant medications are eliminated or required on no more than a prn basis, the frequency of administration of cromolyn sodium inhalation solution may be titrated downward to the lowest level consistent with the desired effect. The usual decrease is from four to three ampules per day. It is important that the dosage be reduced gradually to avoid exacerbation of asthma.

It is emphasized that in patients whose dosage has been titrated to fewer than four ampules per day, an increase in the dose of cromolyn sodium inhalation solution and the introduction of, or increase in, symptomatic medications may be needed if the patient's clinical condition deteriorates. Corticosteroids In patients chronically receiving corticosteroids for the management of bronchial asthma, the dosage should be maintained following the introduction of cromolyn sodium inhalation solution. If the patient improves, an attempt to decrease corticosteroids should be made.

Even if the corticosteroid-dependent patient fails to show symptomatic improvement following cromolyn sodium inhalation solution administration, the potential to reduce corticosteroids may nonetheless be present. Thus, gradual tapering of corticosteroid dosage may be attempted. It is important that the dose be reduced slowly, maintaining close supervision of the patient to avoid an exacerbation of asthma.

It should be borne in mind that prolonged corticosteroid therapy frequently causes an impairment in the activity of the hypothalamic-pituitary-adrenal axis and a reduction in the size of the adrenal cortex. A potentially critical degree of impairment or insufficiency may persist asymptomatically for some time even after gradual discontinuation of adrenocortical steroids. Therefore, if a patient is subjected to significant stress, such as a severe asthmatic attack, surgery, trauma or severe illness while being treated or within one year (occasionally up to two years) after corticosteroid treatment has been terminated, consideration should be given to reinstituting corticosteroid therapy.

When respiratory function is impaired, as may occur in severe exacerbation of asthma, a temporary increase in the amount of corticosteroids may be requi… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Cromolyn sodium inhalation solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.

⚠️ Warnings 24 words ▾

WARNINGS Cromolyn sodium inhalation solution has no role in the treatment of status asthmaticus. Anaphylactic reactions with cromolyn sodium administration have been reported rarely.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Clinical experience with the use of cromolyn sodium suggests that adverse reactions are rare events. The following adverse reactions have been associated with cromolyn sodium: cough, nasal congestion, nausea, sneezing, and wheezing. Other reactions have been reported in clinical trials; however, a causal relationship could not be established: drowsiness, nasal itching, nose bleed, nose burning, serum sickness, and stomachache.

In addition, adverse reactions have been reported with cromolyn sodium for inhalation capsules. The most common side effects are associated with inhalation of the powder and include transient cough (1 in 5 patients) and mild wheezing (1 in 25 patients). These effects rarely require treatment or discontinuation of the drug.

Information on the incidence of adverse reactions to cromolyn sodium for inhalation capsules has been derived from U.S. postmarketing surveillance experience. The following adverse reactions attributed to cromolyn sodium, based upon recurrence following readministration, have been reported in less than 1 in 10,000 patients: laryngeal edema, swollen parotid gland, angioedema, bronchospasm, joint swelling and pain, dizziness, dysuria and urinary frequency, nausea, cough, wheezing, headache, nasal congestion, rash, urticaria and lacrimation.

Other adverse reactions have been reported in less than 1 in 100,000 patients, and it is unclear whether these are attributable to the drug: anaphylaxis, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, pulmonary infiltrates with eosinophilia, polymyositis, exfoliative dermatitis, hemoptysis, anemia, myalgia, hoarseness, photodermatitis, and vertigo. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 130 words ▾

Drug Interaction During Pregnancy Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses up to 540 mg/kg (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) increased both resorptions and malformations.

The addition of cromolyn sodium (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) to isoproterenol (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) appears to have increased the incidence of both resorptions and malformations.

🤰 Pregnancy 122 words ▾

Pregnancy Teratogenic Effects Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg and 164 mg/kg, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg produced no evidence of fetal malformations. These doses represent approximately 27, 17, and 98 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis. Adverse fetal effects (increased resorptions and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

🧓 Geriatric Use 45 words ▾

Geriatric Use Clinical studies of cromolyn sodium inhalation solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 141 words ▾

OVERDOSAGE There is no clinical syndrome associated with an overdosage of cromolyn sodium. Acute toxicity testing in a wide variety of species has demonstrated that toxicity with cromolyn sodium occurs only with very high exposure levels, regardless of whether administration was parenteral, oral or by inhalation. Parenteral administration in mice, rats, guinea pigs, hamsters, and rabbits demonstrated a median lethal dose of approximately 4000 mg/kg.

Intravenous administration in monkeys also indicated a similar pattern of toxicity. The highest dose administered by the oral route in rats and mice was 8000 mg/kg, (approximately 261 and 130 times, respectively, the maximum recommended human daily inhalation dose on a mg/m 2 basis) and at this dose level no deaths occurred. By inhalation, even in long term studies, it proved impossible to achieve toxic dose levels of cromolyn sodium in a range of mammalian species.

🧬 Clinical Pharmacology 142 words ▾

CLINICAL PHARMACOLOGY In vitro and in vivo animal studies have shown that cromolyn sodium inhibits sensitized mast cell degranulation which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of mediators from mast cells. Studies show that cromolyn sodium indirectly blocks calcium ions from entering the mast cell, thereby preventing mediator release.

Cromolyn sodium inhibits both the immediate and non-immediate bronchoconstrictive reactions to inhaled antigen. Cromolyn sodium also attenuates bronchospasm caused by exercise, toluene diisocyanate, aspirin, cold air, sulfur dioxide, and environmental pollutants. Cromolyn sodium has no intrinsic bronchodilator or antihistamine activity.

After administration by inhalation, approximately 8% of the total cromolyn sodium dose administered is absorbed and rapidly excreted unchanged, approximately equally divided between urine and bile. The remainder of the dose is either exhaled or deposited in the oropharynx, swallowed and excreted via the alimentary tract.

📦 How Supplied / Storage and Handling 165 words ▾

HOW SUPPLIED Cromolyn sodium inhalation solution, USP is a clear, colorless to pale yellow solution, practically free from any visible particles supplied in 2mL fill in 3mL BFS (Blow Fill Seal) ampule with twist off cap. Each 2 mL ampule contains 20 mg cromolyn sodium, USP, in water for injection, USP. 2mL fill in 3mL BFS ampule NDC 42571-350-08 Inner Carton of 12 BFS ampules in a PVC Rondo Tray NDC 42571-350-08 Outer Carton of 60 x 2 mL Single-Dose Ampules (5 inner cartons of twelve 2 mL BFS Ampules) NDC 42571-350-09 Outer Carton of 120 x 2 mL Single-Dose Ampules (10 inner cartons of twelve 2 mL BFS Ampules) NDC 42571-350-50 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Do not use if solution is discolored or contains a precipitate. Retain in rondo tray until time of use. PROTECT FROM LIGHT.

Manufactured by: Micro Labs Limited Bangalore-560 099, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev.03/2022

📋 Description 123 words ▾

DESCRIPTION The active ingredient of cromolyn sodium inhalation solution, USP is cromolyn sodium, USP. It is an inhaled anti-inflammatory agent for the preventive management of asthma. Cromolyn sodium, USP is chemically designated as disodium 5,5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4 H -1-benzopyran-2- carboxylate].

The molecular formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Cromolyn sodium, USP is a water soluble, odorless, white, hydrated crystalline powder. It is tasteless at first, but leaves a slightly bitter after taste.

Cromolyn sodium inhalation solution, USP is clear, colorless to pale yellow, sterile, and has a target pH of 5.5. The molecular structure is: Each 2 mL ampule of cromolyn sodium, USP contains 20 mg cromolyn sodium, USP in water for injection, USP. cromolynsodium-structure.jpg

💬 Information for Patients 89 words ▾

Information for Patients Cromolyn sodium is to be taken as directed by the physician. Because it is preventive medication, it may take up to four weeks before the patient experiences maximum benefit. Cromolyn sodium should be used in a power-driven nebulizer with an adequate airflow rate equipped with a suitable face mask or mouthpiece.

Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established. For additional information, see the accompanying leaflet entitled Living a Full Life with Asthma.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Occasionally, patients may experience cough and/or bronchospasm following inhalation of cromolyn sodium. At times, patients who develop bronchospasm may not be able to continue cromolyn sodium administration despite prior bronchodilator administration. Rarely, very severe bronchospasm has been encountered.

Symptoms of asthma may recur if cromolyn sodium is reduced below the recommended dosage or discontinued. Information for Patients Cromolyn sodium is to be taken as directed by the physician. Because it is preventive medication, it may take up to four weeks before the patient experiences maximum benefit.

Cromolyn sodium should be used in a power-driven nebulizer with an adequate airflow rate equipped with a suitable face mask or mouthpiece. Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established. For additional information, see the accompanying leaflet entitled Living a Full Life with Asthma.

Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous treatment at doses up to 75 mg/kg six days per week) showed no neoplastic effects. These doses correspond to approximately 1.0, 0.3, and 2 times, respectively, the maximum recommended human daily inhalation dose on a mg/m 2 basis.

Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes. No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day in males and 100 mg/kg/day in females. These doses are approximately 18 and 10 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis.

Pregnancy Teratogenic Effects Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg and 164 mg/kg, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg produced no evidence of fetal malformations. These doses represent approximately 27, 17, and 98 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis. Adverse fetal effects (increased resorptions and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Drug Interaction During Pregnancy Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice.

Cromolyn sodium alone in doses up to 540 mg/kg (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) increased both resorptions and malformations. The addition of cromolyn sodium (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) to isoproterenol (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m 2 basis) appears to have increased the incidence of both resorptions and malformations.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution sh… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cromolyn sodium is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 176 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous treatment at doses up to 75 mg/kg six days per week) showed no neoplastic effects. These doses correspond to approximately 1.0, 0.3, and 2 times, respectively, the maximum recommended human daily inhalation dose on a mg/m 2 basis.

Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes. No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day in males and 100 mg/kg/day in females. These doses are approximately 18 and 10 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis.

📄 Patient Package Insert ~1 min read ▾

Instructions for the Use of CROMOLYN SODIUM INHALATION SOLUTION USP An aqueous solution for nebulization NOT FOR INJECTION For best results, follow these instructions exactly and observe Care and Storage directions. METHOD OF ADMINISTRATION Cromolyn sodium inhalation solution is recommended for use in a power driven nebulizer operated at an airflow rate of 6 to 8 liters per minute and equipped with a suitable face mask. Hand-operated nebulizers are not suitable for the administration of cromolyn sodium inhalation solution.

Your doctor will advise on the choice of a suitable nebulizer and how it should be used. Do not use any appliance without consulting your doctor. Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established.

DOSAGE Nebulization should be carried out four times a day at regular intervals, or as directed by your doctor. Use the contents of a fresh ampule each time. INHALATION Once the nebulizer has been assembled and contains cromolyn sodium inhalation solution, hold the mask close to the patient’s face and switch on the device.

The patient should breathe in through the mouth and out through the nose in a normal, relaxed manner. Nebulization should take approximately five to ten minutes. 1.

Open the carton, take out rondo tray as shown in (Figure 1). Figure 1 2. Remove the ampule(s) from rondo tray as shown in (Figure 2).

Figure 2 3. Open the ampule by twisting off the tabbed top section as shown in (Figure 3). Figure 3 4.

Squeeze the contents of the unit-dose ampule into the solution container of your nebulizer (Figure 4). Figure 4 Discard the empty unit-dose ampule. Manufactured by: Micro Labs Limited Bangalore-560 099, INDIA.

Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev.03/2022 figure 1 figure 2 figure 3 figure 4

📄 Package Label / Principal Display Panel 93 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-350-08 Cromolyn Sodium Inhalation Solution, USP 20 mg/2 mL For Oral Inhalation Use Only Not For Injection Aqueous Solution for Nebulization 2 mL Single-Dose Ampule NDC 42571-350-08 Cromolyn Sodium Inhalation Solution, USP 20 mg/2 mL For Oral Inhalation Use Only Not For Injection Aqueous Solution for Nebulization 12 x 2mL Single-Dose Ampules NDC 42571-350-09 Cromolyn Sodium Inhalation Solution, USP 20 mg/2 mL For Oral Inhalation Use Only Not For Injection Aqueous Solution for Nebulization 5 Cartons of twelve 2 mL Ampoules each (60 Single-Dose Ampoules) cromolynsodium-ampulelabel.jpg cromolynsodium-innercarton.jpg cromolynsodium-outtercarton.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Medicare Part D (outpatient prescription) spending for Cromolyn Sodium — the program that covers self-administered drugs. 7 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 Cromolyn Sodium. 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
$3.73M
Claims incl. refills
26.3K
Beneficiaries
18.7K
Spend / beneficiary
$199.42
Spend / claim
$142.02
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 12 ampules (42571-0350-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Micro Labs Limited 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7631 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 42571-0348-05 · Micro 42571-0353-38 · Micro →
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.