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NDC 53002-0140-01 Cromolyn Sodium 40 mg/mL Details

Cromolyn Sodium 40 mg/mL

Cromolyn Sodium is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is CROMOLYN SODIUM.

MedlinePlus Drug Summary

Cromolyn ophthalmic is used to treat the symptoms of allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances) and keratitis (a condition that causes swelling of the cornea [tissue in the front of the eye] that causes eye redness, pain, and tearing and changes in vision) in adults and children 4 years of age and older. Cromolyn is in a class of medications called mast cell stabilizers. It works by preventing the release of substances that cause inflammation (swelling) of the eyes.

Related Packages: 53002-0140-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cromolyn Ophthalmic

Product Information

NDC	53002-0140
Product ID	53002-0140_8d26f91b-2e2b-43eb-a8ab-7bc6cedd2210
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cromolyn Sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cromolyn Sodium
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	40
Active Ingredient Units	mg/mL
Substance Name	CROMOLYN SODIUM
Labeler Name	RPK Pharmaceuticals, Inc.
Pharmaceutical Class	Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075282
Listing Certified Through	2024-12-31

Package

NDC 53002-0140-01 (53002014001)

Pricing Information	N/A
NDC Package Code	53002-0140-1
Billing NDC	53002014001
Package	10 mL in 1 BOTTLE, PLASTIC (53002-0140-1)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N