NDC 0069-0338

Revatio

Sildenafil Citrate

Revatio is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Sildenafil Citrate.

• Product ID: 0069-0338_1326290c-2cdf-48ba-8ada-d89564cc7bf4
• NDC: 0069-0338
• Product Type: Human Prescription Drug
• Proprietary Name: Revatio
• Generic Name: Sildenafil Citrate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-11-18
• Marketing Category: NDA / NDA
• Application Number: NDA022473
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: SILDENAFIL CITRATE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0069-0338-01

1 VIAL in 1 CARTON (0069-0338-01) > 12.5 mL in 1 VIAL

• Marketing Start Date: 2009-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0338-01 [00069033801]

Revatio INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA022473
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-11-18

Drug Details

Active Ingredients

Ingredient	Strength
SILDENAFIL CITRATE	.8 mg/mL

OpenFDA Data

• SPL SET ID: f158fe10-d5dc-4432-b2c9-fc665401291b
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • BW9B0ZE037
• RxNorm Concept Unique ID - RxCUI:
  • 1307427
  • 1307431
  • 882530
  • 882527
  • 577033
  • 581645
• UPC Code:
  • 0300690338019

Pharmacological Class

• Phosphodiesterase 5 Inhibitor [EPC]
• Phosphodiesterase 5 Inhibitors [MoA]

NDC Crossover Matching brand name "Revatio" or generic name "Sildenafil Citrate"

NDC	Brand Name	Generic Name
0069-0336	Revatio	sildenafil citrate
0069-0338	Revatio	sildenafil citrate
0069-4190	Revatio	sildenafil citrate
0179-0160	Sildenafil	sildenafil citrate
27808-163	Sildenafil	sildenafil citrate
43063-550	Sildenafil	sildenafil citrate
43353-345	Sildenafil	sildenafil citrate
50436-0033	Sildenafil	sildenafil citrate
0904-6671	SILDENAFIL CITRATE	SILDENAFIL CITRATE
13668-185	SILDENAFIL CITRATE	SILDENAFIL CITRATE
50090-3905	SILDENAFIL CITRATE	SILDENAFIL CITRATE
0069-4200	Viagra	sildenafil citrate
0069-4210	Viagra	sildenafil citrate
0069-4220	Viagra	sildenafil citrate
21695-157	Viagra	sildenafil citrate
21695-158	Viagra	sildenafil citrate
43063-256	Viagra	sildenafil citrate
43353-764	Viagra	sildenafil citrate
50090-0619	Viagra	sildenafil citrate