NDC 70518-1216

Sildenafil

Sildenafil

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

Product ID70518-1216_7d7acfaa-e17d-d0d7-e053-2a91aa0aa4ed
NDC70518-1216
Product TypeHuman Prescription Drug
Proprietary NameSildenafil
Generic NameSildenafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA077342
Labeler NameREMEDYREPACK INC.
Substance NameSILDENAFIL CITRATE
Active Ingredient Strength100 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1216-2

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1216-2)
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1216-0 [70518121600]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-17

NDC 70518-1216-3 [70518121603]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-20

NDC 70518-1216-1 [70518121601]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-21

NDC 70518-1216-2 [70518121602]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-07

Drug Details

Active Ingredients

IngredientStrength
SILDENAFIL CITRATE100 mg/1

OpenFDA Data

SPL SET ID:237ea131-81b9-4281-b307-c0cc551ee012
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314229
  • Pharmacological Class

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

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

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

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