NDC 70518-0513

Lamivudine

Lamivudine

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

Product ID70518-0513_5d962500-6632-3c28-e053-2a91aa0af1b9
NDC70518-0513
Product TypeHuman Prescription Drug
Proprietary NameLamivudine
Generic NameLamivudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA204528
Labeler NameREMEDYREPACK INC.
Substance NameLAMIVUDINE
Active Ingredient Strength150 mg/1
Pharm ClassesHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0513-1

8 TABLET, FILM COATED in 1 BLISTER PACK (70518-0513-1)
Marketing Start Date2017-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0513-0 [70518051300]

Lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-09
Marketing End Date2020-04-06
Inactivation Date2020-01-31
Reactivation Date2020-04-06

NDC 70518-0513-1 [70518051301]

Lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-09
Marketing End Date2020-04-06
Inactivation Date2020-01-31
Reactivation Date2020-04-06

Drug Details

Active Ingredients

IngredientStrength
LAMIVUDINE150 mg/1

OpenFDA Data

SPL SET ID:7425eb2d-3d55-4045-ac30-df40e6a4262a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199147
  • Pharmacological Class

    • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Nucleoside Analog [EXT]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    0904-6583LAMIVUDINElamivudine
    10135-605LamivudineLamivudine
    31722-001lamivudinelamivudine
    31722-752LamivudineLamivudine
    31722-753LamivudineLamivudine
    31722-754LamivudineLamivudine
    33342-001LamivudineLamivudine
    33342-002LamivudineLamivudine
    68180-603LamivudineLamivudine
    68180-602LamivudineLamivudine
    69097-167LAMIVUDINELAMIVUDINE
    69097-166LAMIVUDINELAMIVUDINE
    70518-0540LamivudineLamivudine
    70518-0440LamivudineLamivudine
    70518-0513LamivudineLamivudine
    70518-0690LamivudineLamivudine
    70518-1083LamivudineLamivudine
    70518-1084LamivudineLamivudine
    70518-1634LamivudineLamivudine
    70518-1933LamivudineLamivudine
    50268-460LamivudineLamivudine
    50268-459LamivudineLamivudine
    50742-623LamivudineLamivudine
    50742-624LamivudineLamivudine
    51293-832LamivudineLamivudine
    53808-0843LAMIVUDINELAMIVUDINE
    53808-0844LAMIVUDINELAMIVUDINE
    54838-566LamivudineLamivudine
    57237-274LamivudineLamivudine
    60429-354LAMIVUDINELAMIVUDINE
    60687-362LamivudineLamivudine
    60429-353LAMIVUDINELAMIVUDINE
    60505-3250LamivudineLamivudine
    60505-3252LAMIVUDINELAMIVUDINE
    60505-3251LAMIVUDINELAMIVUDINE
    63629-5014LamivudineLamivudine
    64380-711LamivudineLamivudine
    64330-001LamivudineLamivudine
    64380-710LamivudineLamivudine
    65862-055LamivudineLamivudine
    65862-026LamivudineLamivudine
    65862-552LamivudineLamivudine
    65862-553LamivudineLamivudine
    65862-025LamivudineLamivudine
    66993-478LamivudineLamivudine
    69967-003LamivudineLamivudine
    69967-004LamivudineLamivudine
    70518-2067LamivudineLamivudine
    70518-2070LamivudineLamivudine
    0173-0662EPIVIRlamivudine

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