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Cromolyn Sodium 20 mg/2mL Solution — NDC 00172-6406-49 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cromolyn Sodium 20 mg/2mL Solution — NDC 0172-6406-49 (Billing 00172-6406-49)

by Teva Pharmaceuticals USA, Inc. · 12 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

This is a package of Cromolyn Sodium 20 mg/2mL Solution from Teva Pharmaceuticals USA, Inc., marketed since Jan 2000 and currently FDA-listed; retail pharmacies pay about $0.9626 per mL (NADAC). It is this product's only package size.

NDC 00172-6406-49
🏷️ FDA NDC (as labeled) 0172-6406-49 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 0172-6406-49 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0172 labeler · 6406 product · 49 package
Package marketed since
Jan 18, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0172640649 8
Medicaid fills, this package
362 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0172-6406-49
Product NDC 0172-6406
11-digit billing NDC 00172640649
NCPDP billing unit ML — per mL (volume)
RxCUI 831246
UNII Q2WXR1I0PK
Application # ANDA075271
SPL Set ID 8fe37a7a-edd6-4733-bb7e-e01c1906aeba
Established class (EPC) Mast Cell Stabilizer
Physiologic effect Decreased Histamine Release
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-01-18
Route INTRABRONCHIAL
Dosage form SOLUTION
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 0172-6406-49 — 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 → 00172-6406-49. 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
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 $0.8225 $98.70 / 120 ml
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)0172-6406-49
11-digit billing NDC00172-6406-49
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7631
DescriptorCROMOLYN SODIUM, INHALATION SOLUTION 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 Marketing startMarketing endStatus
00172-6406-49 You're viewing this Main listing 12 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE 2000-01-18 — Active

Therapeutic equivalents

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

🏛️
2000
On the market since
Jan 2000
📍
2026
Currently FDA-listed
26 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerTeva Pharmaceuticals USA, Inc.
Application holderTEVA PHARMACEUTICALS USA
FDA applicationANDA075271 (ANDA)
Labeler code00172
First marketedJan 2000
Product typeHuman Prescription Drug
Portfolio504 products on file

More NDCs from Teva Pharmaceuticals USA, Inc. labeler code 00172

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 109 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 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 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 vial 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 vial 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 vials 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 vials 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 required to regain… [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.

🔄 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 125 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B 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 resorption 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 128 words ▾

HOW SUPPLIED Cromolyn sodium inhalation solution, USP Unit-Dose 2 mL Vial is supplied as a colorless to pale yellow solution containing 20 mg cromolyn sodium, USP, in water for injection, USP, with 5 vials per foil pouch in a carton as listed below. 60 vials per carton (NDC 0172-6406-49). Each vial is made from a low density polyethylene (LDPE) resin.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not use if solution is discolored or contains a precipitate. Retain in foil pouch until time of use.

PROTECT FROM LIGHT. Keep this and all medications out of the reach of children. Manufactured In England By: Norton Healthcare Limited Runcorn, Cheshire WA7 3FA UK Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.

B 12/2023

📋 Description 124 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 aftertaste.

Cromolyn sodium inhalation solution USP is clear, colorless to pale yellow, sterile and has a target pH of 5.5. The structural formula is: Each 2 mL vial for oral inhalation use only contains 20 mg cromolyn sodium, USP in water for injection, USP. structure

💬 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 Pregnancy Category B 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 resorption 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 hu… [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 ~3 min read ▾

LIVING A FULL LIFE WITH ASTHMA PATIENT INSTRUCTIONS Cromolyn Sodium Inhalation Solution, USP You or your child may be among the millions of Americans who have asthma. For most patients, asthma need not limit your lifestyle, if you closely follow the asthma management plan your doctor provides you. Your doctor has given you this instruction sheet to help you learn more about asthma and ways to control it.

WHAT IS ASTHMA? Asthma is a disease that causes patients to have difficulty breathing. Asthma “attacks” occur when the air passages (airways) to the lungs close up, blocking air from passing through.

The closing up is caused by two things: The muscles around the airways tighten (constrict) making the airway narrower, and The passage lining swells and produces larger amounts of mucus (a sticky liquid normally found in airways). This swelling is caused by a certain type of inflammation that can build up in the airways of patients with asthma. Inflammation and the airway sensitivity that results from it cause further attacks to occur.

WHAT CAUSES THESE ATTACKS? Asthma experts know that patients with asthma have attacks because their airways are inflamed and over reactive. Their lungs become super-sensitive to certain irritants or “triggers”, such as cold dry air, pollen, smoke, or cat dander.

In the presence of such triggers, someone with asthma may have an attack, and attacks may occur more often. Asthma triggers fall into 6 categories: Substances that cause allergies (pollens, animal dander, molds, house dust, some foods and medicines) Infections that affect breathing (colds, flu) Emotional stress (difficult situations at home, school, or work) Strenuous exercise Irritating gases (chlorine, perfume, tobacco smoke) Sudden changes in temperature or humidity HOW TO PREVENT ASTHMA ATTACKS No medicine or procedure will “cure” asthma.

The key to asthma relief, therefore, is to prevent attacks and to relieve attack symptoms if they do occur. A successful prevention plan* will do the following: Keep your activities, including exercise, at normal levels. Keep your lungs functioning normally or at a near-normal level.

Prevent symptoms such as coughing or breathlessness that can keep you up at night, or occur in the early morning hours, or after exertion. Prevent asthma attacks from happening. Avoid unpleasant or harmful side effects that may result from using asthma medicine.

The best way to prevent asthma attacks is to avoid the triggers that bother you or your child. Try to identify the specific things that cause problems for you - things such as certain foods, house dust, or animal dander. Avoiding these triggers may be difficult or unpleasant.

You may need to find a new home for a family pet or remove a carpet or a favorite stuffed toy. Even though these steps are difficult, they may be necessary in order to help prevent asthma attacks. If house dust is a trigger, remove dust-collectors such as feather pillows, mattresses, quilts, and carpets from the bedroom.

Mattresses and pillows can be covered with allergen-free covers. If a certain food triggers attacks, keep it out of your diet. Irritants in the air can be reduced by air conditioning, electrostatic air filters, or small-pore (HEPA) filters.

Be careful of certain medicines. Aspirin and aspirin-like pain relievers, for example, can trigger attacks in some people and should be avoided if they do. * Adapted from the National Heart, Lung, and Blood Institute: Guidelines for the Diagnosis and Management of Asthma. National Asthma Education Program, Expert Panel Report, 1991.

OTHER DO’S AND DON’TS Anyone with asthma should stick to a healthy, balanced diet, get lots of rest and moderate exercise, and follow these do’s and don’ts: Don’t smoke, and don’t stay in the same room with people that do. Avoid fresh paint. Avoid sudden changes of temperature.

Don’t go in and out of extremely cool air-conditioned buildings during hot weather. Stay home in extremely cold weather, if possible. Sta… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 47 words ▾

Package/Label Display Panel NDC 0172-6406-49 Cromolyn Sodium Inhalation Solution, USP 20 mg/2 mL Steri-Neb™ brand of Sterile Unit-Dose Vials For Oral Inhalation Use Only Not for Injection Aqueous Solution for Nebulization PRESERVATIVE FREE Rx only 12 pouches of five 2 mL vials each (60 unit-dose vials) carton

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

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 this package alone, 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
362
Units reimbursed last 4 qtrs
81.1K
Gross reimbursed last 4 qtrs
$66.7K
Avg / prescription
$184.24
Avg / unit
$0.8225
Latest quarter Q1 2026
111Rx
Medicaid pays / mL
$0.8225
gross reimbursed
vs
NADAC / mL
$0.9626
acquisition cost
=
Spread
−$0.1401
-15% 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 ⓘ
57% FFS 43% MCO
Fee-for-service · 206 Rx Managed care · 156 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,120 units · 39.9 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,160 units · 36.5 per 100k residents WI Michigan: no data reported MI New York: 32,760 units · 167 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 13,020 units · 104 per 100k residents IL Indiana: no data reported IN Ohio: 7,200 units · 61.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 3,240 units · 34.9 per 100k residents NJ Massachusetts: no data reported MA California: 12,360 units · 31.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,560 units · 17.9 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 5,664 units · 25.1 per 100k residents FL
Units reimbursed · per 100k residents
17.9167
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 York 167 /100k
2 Illinois 104 /100k
3 Ohio 61.1 /100k
4 Washington 39.9 /100k
5 Wisconsin 36.5 /100k
6 New Jersey 34.9 /100k
7 California 31.7 /100k
8 Florida 25.1 /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 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.
← 00172-5729-60 · Teva 00172-7313-20 · Teva →
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.