NDC 0093-5343

Sildenafil

Sildenafil

Sildenafil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Sildenafil Citrate.

• Product ID: 0093-5343_44301615-f3ab-4456-9c91-81349cb8d1ea
• NDC: 0093-5343
• Product Type: Human Prescription Drug
• Proprietary Name: Sildenafil
• Generic Name: Sildenafil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077342
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: SILDENAFIL CITRATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0093-5343-01

100 TABLET, FILM COATED in 1 BOTTLE (0093-5343-01)

• Marketing Start Date: 2017-12-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-5343-56 [00093534356]

Sildenafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-11

NDC 0093-5343-01 [00093534301]

Sildenafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-11

Drug Details

Active Ingredients

Ingredient	Strength
SILDENAFIL CITRATE	100 mg/1

OpenFDA Data

• SPL SET ID: 5cbac450-f336-45bd-8d10-9ecfd21866eb
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • BW9B0ZE037
• RxNorm Concept Unique ID - RxCUI:
  • 314228
  • 312950
  • 314229
• UPC Code:
  • 0300935341569
  • 0300935343563
  • 0300935342566

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0093-5341	Sildenafil	Sildenafil
0093-5342	Sildenafil	Sildenafil
0093-5343	Sildenafil	Sildenafil
0093-5517	Sildenafil	Sildenafil
0179-0160	Sildenafil	sildenafil citrate
0378-1657	Sildenafil	sildinafil
0378-1658	Sildenafil	sildenafil
0378-1659	Sildenafil	sildenafil
0378-1660	Sildenafil	sildenafil
0591-4050	Sildenafil	Sildenafil
68001-176	Sildenafil	Sildenafil
68001-363	Sildenafil	Sildenafil
68071-2072	Sildenafil	Sildenafil
68071-1979	Sildenafil	Sildenafil
68071-1687	Sildenafil	Sildenafil
68071-3137	Sildenafil	Sildenafil
68071-3329	Sildenafil	Sildenafil
68071-4517	Sildenafil	Sildenafil
68071-4599	Sildenafil	Sildenafil
68071-4617	Sildenafil	Sildenafil
68071-4674	Sildenafil	Sildenafil
68084-869	Sildenafil	Sildenafil
68788-7379	Sildenafil	Sildenafil
68788-7218	Sildenafil	Sildenafil
70518-0438	Sildenafil	Sildenafil
70518-1216	Sildenafil	Sildenafil
70518-1844	Sildenafil	Sildenafil
70859-015	Sildenafil	Sildenafil
71205-088	Sildenafil	Sildenafil
71205-220	Sildenafil	Sildenafil
71335-0969	Sildenafil	Sildenafil
71335-1005	Sildenafil	Sildenafil
71335-0288	Sildenafil	Sildenafil
71335-1028	Sildenafil	Sildenafil
71610-237	Sildenafil	Sildenafil
76519-1135	Sildenafil	Sildenafil
76519-1216	SILDENAFIL	SILDENAFIL
76519-1218	SILDENAFIL	SILDENAFIL
27241-124	Sildenafil	Sildenafil
31722-710	Sildenafil	Sildenafil
31722-776	Sildenafil	Sildenafil
31722-711	Sildenafil	Sildenafil
31722-709	Sildenafil	Sildenafil
33342-121	Sildenafil	Sildenafil
42291-747	Sildenafil	Sildenafil
42291-748	Sildenafil	Sildenafil
42291-746	Sildenafil	Sildenafil
42291-749	Sildenafil	Sildenafil
43063-668	Sildenafil	Sildenafil
43063-550	Sildenafil	Sildenafil