NDC 17478-066

Nedocromil Sodium

Nedocromil Sodium

Nedocromil Sodium is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Nedocromil Sodium.

• Product ID: 17478-066_005c5488-a9b1-4bc0-b6f3-5ce763e9f2dc
• NDC: 17478-066
• Product Type: Human Prescription Drug
• Proprietary Name: Nedocromil Sodium
• Generic Name: Nedocromil Sodium
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2012-09-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090638
• Labeler Name: Akorn, Inc.
• Substance Name: NEDOCROMIL SODIUM
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 17478-066-10

1 BOTTLE, DROPPER in 1 CARTON (17478-066-10) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2012-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17478-066-10 [17478006610]

Nedocromil Sodium SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA090638
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-09-10

Drug Details

Active Ingredients

Ingredient	Strength
NEDOCROMIL SODIUM	20 mg/mL

OpenFDA Data

• SPL SET ID: e5c6b084-f6f8-4c14-a742-48b0f4d9b9a7
• Manufacturer:
  • Akorn, Inc.
• UNII:
  • ET8IF4KS1T
• RxNorm Concept Unique ID - RxCUI:
  • 897292

Pharmacological Class

• Decreased Histamine Release [PE]
• Mast Cell Stabilizer [EPC]

NDC Crossover Matching brand name "Nedocromil Sodium" or generic name "Nedocromil Sodium"

NDC	Brand Name	Generic Name
17478-066	Nedocromil Sodium	Nedocromil Sodium
0023-8842	ALOCRIL	nedocromil sodium