NDC 42291-747

Sildenafil

Sildenafil

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

• Product ID: 42291-747_7d791848-dd19-a47b-e053-2a91aa0ab43a
• NDC: 42291-747
• Product Type: Human Prescription Drug
• Proprietary Name: Sildenafil
• Generic Name: Sildenafil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077342
• Labeler Name: AvKARE, Inc.
• Substance Name: SILDENAFIL CITRATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42291-747-01

100 TABLET, FILM COATED in 1 BOTTLE (42291-747-01)

• Marketing Start Date: 2018-05-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42291-747-06 [42291074706]

Sildenafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-09-04

NDC 42291-747-01 [42291074701]

Sildenafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-29

NDC 42291-747-30 [42291074730]

Sildenafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-29

NDC 42291-747-04 [42291074704]

Sildenafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077342
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-29
• Marketing End Date: 2018-09-04

NDC 42291-747-02 [42291074702]

Sildenafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-29

Drug Details

Active Ingredients

Ingredient	Strength
SILDENAFIL CITRATE	50 mg/1

OpenFDA Data

• SPL SET ID: 6d5b01df-db24-06bd-e053-2991aa0ac22f
• Manufacturer:
  • AvKARE, Inc.
• UNII:
  • BW9B0ZE037
• RxNorm Concept Unique ID - RxCUI:
  • 314228
  • 312950
  • 314229
• UPC Code:
  • 0342291748309
  • 0342291747302
  • 0342291746305

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