NDC 0527-5121

Nystatin Oral Suspension

Nystatin Oral Suspension

Nystatin Oral Suspension is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Nystatin.

• Product ID: 0527-5121_67824691-043e-455c-aeb2-92540dd8ace6
• NDC: 0527-5121
• Product Type: Human Prescription Drug
• Proprietary Name: Nystatin Oral Suspension
• Generic Name: Nystatin Oral Suspension
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2005-06-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065148
• Labeler Name: Lannett Company, Inc.
• Substance Name: NYSTATIN
• Active Ingredient Strength: 100000 [USP'U]/mL
• Pharm Classes: Polyene Antifungal [EPC],Polyenes [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0527-5121-62

1 BOTTLE, DROPPER in 1 CARTON (0527-5121-62) > 60 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2005-06-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0527-5121-62 [00527512162]

Nystatin Oral Suspension SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065148
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-06-28

NDC 0527-5121-70 [00527512170]

Nystatin Oral Suspension SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065148
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-06-28

Drug Details

Active Ingredients

Ingredient	Strength
NYSTATIN	100000 [USP'U]/mL

OpenFDA Data

• SPL SET ID: fb74df16-44c4-48a4-907c-91c5c7434a63
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • BDF1O1C72E
• UPC Code:
  • 0305275121703

Pharmacological Class

• Polyene Antifungal [EPC]
• Polyenes [CS]

NDC Crossover Matching brand name "Nystatin Oral Suspension" or generic name "Nystatin Oral Suspension"

NDC	Brand Name	Generic Name
0527-5121	Nystatin Oral Suspension	Nystatin Oral Suspension
68071-2644	Nystatin Oral Suspension	Nystatin Oral Suspension
68788-7956	Nystatin Oral Suspension	Nystatin Oral Suspension
80432-003	Nystatin	Nystatin Oral Suspension