NDC 11980-022

BLEPHAMIDE

Sulfacetamide Sodium And Prednisolone Acetate

BLEPHAMIDE is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Sulfacetamide Sodium; Prednisolone Acetate.

• Product ID: 11980-022_01643437-7cdb-4f32-bb3e-8be326b99127
• NDC: 11980-022
• Product Type: Human Prescription Drug
• Proprietary Name: BLEPHAMIDE
• Generic Name: Sulfacetamide Sodium And Prednisolone Acetate
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1961-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA012813
• Labeler Name: Allergan, Inc.
• Substance Name: SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE
• Active Ingredient Strength: 100 mg/mL; mg/mL
• Pharm Classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 11980-022-05

1 BOTTLE, DROPPER in 1 CARTON (11980-022-05) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 1961-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11980-022-10 [11980002210]

BLEPHAMIDE SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA012813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1961-10-01

NDC 11980-022-05 [11980002205]

BLEPHAMIDE SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA012813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1961-10-01

NDC 11980-022-06 [11980002206]

BLEPHAMIDE SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA012813
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-10-29
• Marketing End Date: 2012-01-18

Drug Details

Active Ingredients

Ingredient	Strength
SULFACETAMIDE SODIUM	100 mg/mL

OpenFDA Data

• SPL SET ID: 0e5644af-2a3c-493a-bc24-174e5f36235b
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 8B2807733D
  • 4NRT660KJQ
• RxNorm Concept Unique ID - RxCUI:
  • 1012017
  • 1012015
• UPC Code:
  • 0311980022051

Pharmacological Class

• Sulfonamide Antibacterial [EPC]
• Sulfonamides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Sulfonamide Antibacterial [EPC]
• Sulfonamides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

Medicade Reported Pricing

11980022810 FML FORTE 0.25% EYE DROPS

Pricing Unit: ML | Drug Type:

11980022805 FML FORTE 0.25% EYE DROPS

Pricing Unit: ML | Drug Type:

11980002210 BLEPHAMIDE EYE DROPS

Pricing Unit: ML | Drug Type:

11980002205 BLEPHAMIDE EYE DROPS

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "BLEPHAMIDE" or generic name "Sulfacetamide Sodium And Prednisolone Acetate"

NDC	Brand Name	Generic Name
0023-0313	BLEPHAMIDE	sulfacetamide sodium and prednisolone acetate
11980-022	BLEPHAMIDE	sulfacetamide sodium and prednisolone acetate