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CROMOLYN SODIUM 100 mg/5mL Solution, Concentrate — NDC 81665-104-96 (Billing 81665-0104-96)

by Omnivium Pharmaceuticals LLC · 12 POUCH in 1 CARTON / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

This is a package of CROMOLYN SODIUM 100 mg/5mL Solution, Concentrate from Omnivium Pharmaceuticals LLC, marketed since Aug 2024 and currently FDA-listed; retail pharmacies pay about $0.3490 per mL (NADAC). It is this product's only package size.

NDC 81665-0104-96
🏷️ FDA NDC (as labeled) 81665-104-96 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage ⇄ 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

⚠️
Active FDA shortage. Cromolyn Sodium Concentrate is currently reported in shortage by the FDA. Available Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81665-104-96
Product NDC 81665-104
11-digit billing NDC 81665010496
NCPDP billing unit ML — per mL (volume)
RxCUI 831261
UNII Q2WXR1I0PK
Application # ANDA209264
SPL Set ID a742664b-265e-49f9-9744-d04e1fb620ae
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 2024-08-31
Route ORAL
Dosage form SOLUTION, CONCENTRATE
Substance CROMOLYN SODIUM
TE code (Orange Book) AA · RLD · RS

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

GPI-14 52160015101320
GCN Seq No 025061
GCN 16925
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 Z2F
Therapeutic class — specific (HIC3) Mast Cell Stabilizers
AHFS code 48:10.32.00
AHFS class Mast-Cell Stabilizers
FDB label name CROMOLYN 100 MG/5 ML ORAL CONC
FDB brand name Cromolyn Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 025061
  • GCN: 16925
  • GPI-14 (Medi-Span): 52160015101320
  • HICL (First Databank): 004526
  • AHFS class code: 48:10.32.00
  • RxCUI (RxNorm): 831261
Why two NDCs? The FDA registers this code as 81665-104-96 — 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 → 81665-0104-96. 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 100 MG/5 ML ORAL CONC 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 $0.349 $167.52 / 480 ml
Medicaid paysCMS SDUD · 12 mo $0.3624 $173.95 / 480 ml
Medicare drug plans payPart D · Q2 2026 $0.3643 $174.86 / 480 ml
Medicare Part B allowsASP · J8499 No ASP payment limit on file for J8499 this quarter.
NADAC price history (per mL) — tap or hover for the price & month
Mar 2026 May 2026 Jul 2026 Sep 2026 $0.349 $0.314
▲ Up 6% over the last 7 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)81665-104-96
11-digit billing NDC81665-0104-96
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ8499
DescriptorPRESCRIPTION DRUG, ORAL, NON CHEMOTHERAPEUTIC, NOS
Billing units / pkg1 units
How the units are derivedThis package is 5 ML; the HCPCS unit is 1 EA, so one package = 1 billing unit.
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
81665-0104-96 You're viewing this Main listing 12 POUCH in 1 CARTON / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE 2024-08-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
cromolyn sodium 100 mg/5mL 51525-0470-09 Mylan 12 pouches $0.331 AA Discontinued save 5%
Cromolyn Sodium 100 mg/5mL 16571-0600-96 Rising 12 pouches $0.349 AA Availability likely —
Cromolyn Sodium 100 mg/5mL 42571-0132-52 Micro 8 ampules $0.349 AA Availability likely —
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5mL 76204-0025-96 Ritedose 12 pouches $0.349 AA Discontinued —
Cromolyn Sodium 100 mg/5mLthis 81665-0104-96 Omnivium 12 pouches $0.349 AA Availability likely —
Gastrocrom 20 mg/mL 00037-0678-96 Viatris 12 pouches $2.432 AA Availability likely +597%
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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 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.

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

  • 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.

1 inactive ingredient 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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerOmnivium Pharmaceuticals LLC
Application holderAILEX PHARMACEUTICALS LLC
FDA applicationANDA209264 (ANDA)
Labeler code81665
First marketedAug 2024
Product typeHuman Prescription Drug
Portfolio6 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.

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

INDICATIONS AND USAGE: Cromolyn Sodium Oral Solution (Concentrate) is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

⏱️ Dosage and Administration 196 words ▾

DOSAGE AND ADMINISTRATION: NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE . The usual starting dose is as follows: Adults and Adolescents (13 Years and Older): Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years: One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years: Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day.

Patients should be advised that the effect of Cromolyn Sodium Oral Solution (Concentrate) therapy is dependent upon its administration at regular intervals, as directed. Maintenance Dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained.

Administration: Cromolyn Sodium Oral Solution (Concentrate) should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions: Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. Stir solution. Drink all of the liquid.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS: Cromolyn Sodium Oral Solution (Concentrate) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.

⚠️ Warnings 27 words ▾

WARNINGS: The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS: Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Cromolyn Sodium Oral Solution (Concentrate) during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each.

One report of malaise was also recorded. To report SUSPECTED ADVERSE REACTIONS, contact Omnivium Pharmaceuticals LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience.

In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. Other less commonly reported events (the majority representing only a single report) include the following: Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs Neurologic: headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing Psychiatric: psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness Heart Rate: tachycardia, premature ventricular contractions (PVCs), palpitations Respiratory: pharyngitis, dyspnea Miscellaneous: fatigue, edema, unpleasant taste, chest pain, postprandial lightheadedness and lethargy, dysuria, urinary frequency, purpura, hepatic function test abnormal, polycythemia, neutropenia, pancytopenia, tinnitus, lupus erythematosus (LE) syndrome

🤰 Pregnancy ~1 min read ▾

Pregnancy: Pregnancy Category B. In reproductive studies in pregnant mice, rats, and rabbits, cromolyn sodium produced no evidence of fetal malformations at subcutaneous doses up to 540 mg/kg in mice (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis) or at intravenous doses up to 485 mg/kg in rabbits (approximately 4 times the maximum recommended daily oral dose in adults on a mg/m 2 basis).

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: In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis).

Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits.

🧒 Pediatric Use 167 words ▾

Pediatric Use: In adult rats no adverse effects of cromolyn sodium were observed at oral doses up to 6144 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m 2 basis). In neonatal rats, cromolyn sodium increased mortality at oral doses of 1000 mg/kg or greater (approximately 9 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) but not at doses of 300 mg/kg or less (approximately 3 times the maximum recommended daily oral dose in infants on a mg/m 2 basis).

Plasma and kidney concentrations of cromolyn after oral administration to neonatal rats were up to 20 times greater than those in older rats. In term infants up to six months of age, available clinical data suggest that the dose should not exceed 20 mg/kg/day. The use of this product in pediatric patients less than two years of age should be reserved for patients with severe disease in which the potential benefits clearly outweigh the risks.

🧓 Geriatric Use 86 words ▾

Geriatric Use: Clinical studies of Cromolyn Sodium Oral Solution (Concentrate) 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🧬 Clinical Pharmacology 140 words ▾

CLINICAL PHARMACOLOGY: In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the release of mediators from sensitized mast cells. Cromolyn sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell. Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity.

Cromolyn sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of cromolyn sodium was seen after oral administration of 500 mg by mouth to each of 12 volunteers.

From 0.28 to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%.

📦 How Supplied / Storage and Handling 104 words ▾

HOW SUPPLIED: Cromolyn Sodium Oral Solution (Concentrate) is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch. Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water. NDC 81665-104-96 96 ampules x 5 mL (12 pouches x 8 ampules) Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature] and protected from light.

Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children. Store ampules in foil pouch until ready for use.

📋 Description 92 words ▾

DESCRIPTION: Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste.

Cromolyn Sodium Oral Solution (Concentrate) is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate].

The empirical formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic Cromolyn Structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: In view of the biliary and renal routes of excretion of Cromolyn Sodium Oral Solution (Concentrate), consideration should be given to decreasing the dosage of the drug in patients with impaired renal or hepatic function. Carcinogenesis, Mutagenesis, and Impairment of Fertility: In carcinogenicity studies in mice, hamsters, and rats, cromolyn sodium had no neoplastic effects at intraperitoneal doses up to 150 mg/kg three days per week for 12 months in mice, at intraperitoneal 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 in hamsters, and at subcutaneous doses up to 75 mg/kg six days per week for 18 months in rats.

These doses in mice, hamsters, and rats are less than the maximum recommended daily oral dose in adults and children 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. In rats, cromolyn sodium showed no evidence of impaired fertility at subcutaneous doses up to 175 mg/kg in males (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis).

Pregnancy: Pregnancy Category B. In reproductive studies in pregnant mice, rats, and rabbits, cromolyn sodium produced no evidence of fetal malformations at subcutaneous doses up to 540 mg/kg in mice (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis) or at intravenous doses up to 485 mg/kg in rabbits (approximately 4 times the maximum recommended daily oral dose in adults on a mg/m 2 basis).

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: In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis).

Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits.

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 Oral Solution (Concentrate) is administered to a nursing woman. Pediatric Use: In adult rats no adverse effects of cromolyn sodium were observed at oral doses up to 6144 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m 2 basis).

In neonatal rats, cromolyn sodium increased mortality at oral doses of 1000 mg/kg or greater (approximately 9 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) but not at doses of 300 mg/kg or less (approximately 3 times the maximum recommended daily oral dose in infants on a mg/m 2 basis). Plasma and kidney concentrations of cromolyn after oral administration to neonatal rats were up to 20 times greater than those in older rats. In term infants up to six months of age, available clinical data suggest that the dose should not exceed 20 mg/kg/day.

The use of this product in pediatric patients less than two years of age should be reserved for patients with seve… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 38 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 Oral Solution (Concentrate) is administered to a nursing woman.

🔬 Clinical Studies 205 words ▾

CLINICAL STUDIES: Four randomized, controlled clinical trials were conducted with Cromolyn Sodium Oral Solution (Concentrate) in patients with either cutaneous or systemic mastocytosis; two of which utilized a placebo-controlled crossover design, one utilized an active-controlled (chlorpheniramine plus cimetidine) crossover design, and one utilized a placebo-controlled parallel group design. Due to the rare nature of this disease, only 36 patients qualified for study entry, of whom 32 were considered evaluable. Consequently, formal statistical analyses were not performed.

Clinically significant improvement in gastrointestinal symptoms (diarrhea, abdominal pain) were seen in the majority of patients with some improvement also seen for cutaneous manifestations (urticaria, pruritus, flushing) and cognitive function. The benefit seen with Cromolyn Sodium Oral Solution (Concentrate) 200 mg QID was similar to chlorpheniramine (4 mg QID) plus cimetidine (300 mg QID) for both cutaneous and systemic symptoms of mastocytosis. Clinical improvement occurred within 2-6 weeks of treatment initiation and persisted for 2-3 weeks after treatment withdrawal.

Cromolyn Sodium Oral Solution (Concentrate) did not affect urinary histamine levels or peripheral eosinophilia, although neither of these variables appeared to correlate with disease severity. Positive clinical benefits were also reported for 37 of 51 patients who received Cromolyn Sodium Oral Solution (Concentrate) in United States and foreign humanitarian programs.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 188 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility: In carcinogenicity studies in mice, hamsters, and rats, cromolyn sodium had no neoplastic effects at intraperitoneal doses up to 150 mg/kg three days per week for 12 months in mice, at intraperitoneal 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 in hamsters, and at subcutaneous doses up to 75 mg/kg six days per week for 18 months in rats. These doses in mice, hamsters, and rats are less than the maximum recommended daily oral dose in adults and children 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. In rats, cromolyn sodium showed no evidence of impaired fertility at subcutaneous doses up to 175 mg/kg in males (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis).

📄 Patient Package Insert ~1 min read ▾

Patient Instructions Cromolyn Sodium Oral Solution (Concentrate) FOR ORAL USE ONLY – NOT FOR INHALATION OR INJECTION. MUST BE DILUTED. How to Use Cromolyn Sodium Oral Solution (Concentrate): As with all prescription drugs, follow the directions for dosage that your physician recommends.

The effect of Cromolyn Sodium Oral Solution (Concentrate) therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician. Usual Starting Dose: Adults and Adolescents (13 Years and Older): Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years: One ampule four times daily, taken one-half hour before meals and at bedtime.

Note: Your physician may decide to increase OR decrease your dosage to achieve optimum results with Cromolyn Sodium Oral Solution (Concentrate). However, do not change your dose or stop taking Cromolyn Sodium Oral Solution (Concentrate) without first consulting your physician. Care & Storage: Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° - 25°C (68° - 77°F) and protected from light.

Do not use if it contains a precipitate (particles or cloudiness) or becomes discolored. Keep out of the reach of children. Store ampules in foil pouch until ready for use.

Recycling Information: Cromolyn Sodium Oral Solution (Concentrate) ampules are made with a low density polyethylene plastic (recycling material code: LDPE). Call your doctor for medical advice about side effects. You may report side effects to Omnivium Pharmaceuticals LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch..

Directions for Use: 1. Open foil pouch by tearing at serrated edge as shown. 2.

Remove ampule(s) from the strip. 3. Open the ampule by twisting off the tabbed top section.

4. Squeeze liquid contents into a glass of water. Stir solution.

Drink all of the liquid. Discard the empty ampule. Marketed by: Omnivium Pharmaceuticals LLC Rahway, NJ 07065 Rev.: May 2024 RPIN0198 Figure 1 Figure 2 Figure 3 Figure 4 Recycle Figure

📄 Package Label / Principal Display Panel 126 words ▾

Cromolyn Sodium Oral Solution (Concentrate), 100 mg/5 mL Carton Label NDC 81665-104-96 Rx Only Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL FOR ORAL USE ONLY – NOT FOR INHALATION OR INJECTION. Must Be Diluted Marketed by: Omnivium Pharmaceuticals LLC Rahway, NJ 07065 96 Plastic Ampules DESCRIPTION: Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water. NOTE: See package insert for full prescribing information including contraindications, warnings and precautions.

Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature] and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready to use. Cromolyn 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
6K
Units reimbursed last 4 qtrs
5.2M
Gross reimbursed last 4 qtrs
$1.87M
Avg / prescription
$312.61
Avg / unit
$0.3624
Latest quarter Q1 2026
1.9KRx
Medicaid pays / mL
$0.3624
gross reimbursed
vs
NADAC / mL
$0.3490
acquisition cost
=
Spread
+$0.0134
+4% 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 ⓘ
33% FFS 67% MCO
Fee-for-service · 1,993 Rx Managed care · 3,996 Rx
State Medicaid map
Alaska: no data reported AK Maine: 57,480 units · 4,120 per 100k residents ME Washington: 533,000 units · 6,823 per 100k residents WA Idaho: 73,800 units · 3,758 per 100k residents ID Montana: 30,480 units · 2,693 per 100k residents MT North Dakota: 12,680 units · 1,619 per 100k residents ND Minnesota: 93,360 units · 1,627 per 100k residents MN Wisconsin: 121,250 units · 2,052 per 100k residents WI Michigan: 89,730 units · 894 per 100k residents MI New York: 279,296 units · 1,427 per 100k residents NY Vermont: 61,056 units · 9,437 per 100k residents VT New Hampshire: no data reported NH Oregon: 213,160 units · 5,036 per 100k residents OR Nevada: 7,120 units · 223 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 62,760 units · 1,957 per 100k residents IA Illinois: 140,400 units · 1,119 per 100k residents IL Indiana: 69,720 units · 1,016 per 100k residents IN Ohio: 211,280 units · 1,793 per 100k residents OH Pennsylvania: 342,145 units · 2,640 per 100k residents PA New Jersey: 80,600 units · 868 per 100k residents NJ Massachusetts: 628,960 units · 8,984 per 100k residents MA California: 306,000 units · 785 per 100k residents CA Utah: 297,780 units · 8,715 per 100k residents UT Colorado: 218,310 units · 3,714 per 100k residents CO Nebraska: no data reported NE Missouri: 106,680 units · 1,722 per 100k residents MO Kentucky: 134,130 units · 2,964 per 100k residents KY West Virginia: no data reported WV Virginia: 260,958 units · 2,994 per 100k residents VA Maryland: 224,590 units · 3,634 per 100k residents MD Connecticut: 116,566 units · 3,223 per 100k residents CT Rhode Island: 16,080 units · 1,468 per 100k residents RI Arizona: 124,000 units · 1,669 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 11,520 units · 162 per 100k residents TN North Carolina: 132,940 units · 1,227 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 63,840 units · 1,575 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 17,760 units · 161 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 17,280 units · 56.7 per 100k residents TX Florida: 9,720 units · 43.0 per 100k residents FL
Units reimbursed · per 100k residents
43.09,437
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 Vermont 9,437 /100k
2 Massachusetts 8,984 /100k
3 Utah 8,715 /100k
4 Washington 6,823 /100k
5 Oregon 5,036 /100k
6 Maine 4,120 /100k
7 Idaho 3,758 /100k
8 Colorado 3,714 /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.
← 81665-0103-10 · OMNIVIUM 81665-0107-10 · OMNIVIUM →
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.