NDC 76204-025

Cromolyn Sodium Oral Solution (Concentrate)

Cromolyn Sodium Oral Solution (concentrate)

Cromolyn Sodium Oral Solution (Concentrate) is a Oral Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Ritedose Pharmaceuticals, Llc. The primary component is Cromolyn Sodium.

Product ID76204-025_d208df15-c824-6e0d-e053-2a95a90ad1be
NDC76204-025
Product TypeHuman Prescription Drug
Proprietary NameCromolyn Sodium Oral Solution (Concentrate)
Generic NameCromolyn Sodium Oral Solution (concentrate)
Dosage FormSolution, Concentrate
Route of AdministrationORAL
Marketing Start Date2021-12-01
Marketing CategoryANDA /
Application NumberANDA209264
Labeler NameRitedose Pharmaceuticals, LLC
Substance NameCROMOLYN SODIUM
Active Ingredient Strength100 mg/5mL
Pharm ClassesDecreased Histamine Release [PE],Mast Cell Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 76204-025-96

1 POUCH in 1 CARTON (76204-025-96) > 96 AMPULE in 1 POUCH (76204-025-08) > 5 mL in 1 AMPULE
Marketing Start Date2021-12-01
NDC Exclude FlagN
Sample Package?N

Drug Details


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