Cromolyn Sodium
A-s Medication Solutions
Human Prescription Drug
NDC 50090-1202Cromolyn Sodium is a human prescription drug labeled by 'A-s Medication Solutions'. National Drug Code (NDC) number for Cromolyn Sodium is 50090-1202. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Cromolyn Sodium drug includes Cromolyn Sodium - 40 mg/mL . The currest status of Cromolyn Sodium drug is Active.
Drug Information:
| Drug NDC: | 50090-1202 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cromolyn Sodium |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Cromolyn Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | A-s Medication Solutions |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CROMOLYN SODIUM - 40 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 29 Jun, 1999 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA075282 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | A-S Medication Solutions
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 831109
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | Q2WXR1I0PK
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased Histamine Release [PE]
Mast Cell Stabilizer [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50090-1202-0 | 10 mL in 1 BOTTLE, PLASTIC (50090-1202-0) | 28 Nov, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Cromolyn sodium cromolyn sodium cromolyn sodium cromolyn benzalkonium chloride edetate disodium water hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage cromolyn sodium ophthalmic solution usp, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
General Precautions:
General patients may experience a transient stinging or burning sensation following application of cromolyn sodium ophthalmic solution usp, 4%. the recommended frequency of administration should not be exceeded (see dosage and administration ).
Dosage and Administration:
Dosage and administration the dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. one drop contains approximately 1.6 mg cromolyn sodium. patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed. symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. if required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution usp, 4%.
Contraindications:
Contraindications cromolyn sodium ophthalmic solution usp, 4% is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.
Adverse Reactions:
Adverse reactions the most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation. the following adverse reactions have been reported as infrequent events. it is unclear whether they are attributable to the drug: conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes. immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema and rash.
Use in Pregnancy:
Pregnancy
Pediatric Use:
Pediatric use safety and effectiveness in children below the age of 4 years have not been established.
Description:
Description cromolyn sodium ophthalmic solution usp, 4% is a clear, colorless, sterile solution intended for topical ophthalmic use. cromolyn sodium is represented by the following structural formula: chemical name: disodium 5-5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4h-1-benzopyran-2-carboxylate] pharmacologic category: mast cell stabilizer. each ml contains: active: cromolyn sodium 40 mg (4%); preservative: benzalkonium chloride 0.01%. inactives: edetate disodium 0.1% and purified water. hydrochloric acid and/or sodium hydroxide may be added to adjust ph (4.0-7.0). chemicalstructure
Clinical Pharmacology:
Clinical pharmacology in vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. cromolyn sodium acts by inhibiting the release of histamine and srs-a (slow-reacting substance of anaphylaxis) from the mast cell. another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the degranulation of non-sensitized rat mast cells by phospholipase a and the subsequent release of chemical mediators. another study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase a on its specific substrate. cromolyn sodium has no intrinsic vasoconstrictor, antihistaminic or anti-inflammatory activity. cromolyn sodium is poorly absorbed. when multiple doses of cromolyn sodium ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is absorbed into the systemic circulation (pre
Read more...sumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped. in normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, 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 52.6 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 administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects. the average daily maximum dose levels administered in these studies were 192.9 mg/m 2 for mice, 47.2 mg/m 2 for hamsters and 385.8 mg/m 2 for rats. these doses correspond to approximately 6.8, 1.7 and 14 times the maximum daily human dose of 28 mg/m 2 . cromolyn sodium showed no mutagenic potential in the ames salmonella /microsome plate assays, mitotic gene conversion in saccharomycas cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes. no evidence of impaired fertility was shown in laboratory reprod
Read more...uction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m 2 ) in males and 100 mg/kg/day (600 mg/m 2 ) in females. these doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m 2 .
How Supplied:
How supplied product: 50090-1202 ndc: 50090-1202-0 10 ml in a bottle, plastic
Information for Patients:
Information for the patient patients should be advised to follow the patient instructions listed on the information for patients sheet. users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. do not wear contact lenses during treatment with cromolyn sodium ophthalmic solution usp, 4%.
Package Label Principal Display Panel:
Cromolyn sodium label image