Product NDC: | 16571-600 |
Proprietary Name: | CROMOLYN SODIUM |
Non Proprietary Name: | CROMOLYN SODIUM |
Active Ingredient(s): | 100 mg/5mL & nbsp; CROMOLYN SODIUM |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION, CONCENTRATE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16571-600 |
Labeler Name: | Pack Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA202583 |
Marketing Category: | ANDA |
Start Marketing Date: | 20111205 |
Package NDC: | 16571-600-96 |
Package Description: | 12 POUCH in 1 CARTON (16571-600-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE |
NDC Code | 16571-600-96 |
Proprietary Name | CROMOLYN SODIUM |
Package Description | 12 POUCH in 1 CARTON (16571-600-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE |
Product NDC | 16571-600 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | CROMOLYN SODIUM |
Dosage Form Name | SOLUTION, CONCENTRATE |
Route Name | ORAL |
Start Marketing Date | 20111205 |
Marketing Category Name | ANDA |
Labeler Name | Pack Pharmaceuticals, LLC |
Substance Name | CROMOLYN SODIUM |
Strength Number | 100 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] |