NDC 35573-430

Abacavir and Lamivudine

Abacavir And Lamivudine

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

Product ID35573-430_24b2c766-501b-4d7f-99aa-1fd8a8ee3ea4
NDC35573-430
Product TypeHuman Prescription Drug
Proprietary NameAbacavir and Lamivudine
Generic NameAbacavir And Lamivudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA090159
Labeler NameBurel Pharmaceuticals, Inc.
Substance NameABACAVIR SULFATE; LAMIVUDINE
Active Ingredient Strength600 mg/1; mg/1
Pharm ClassesHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],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 Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 35573-430-30

1 BOTTLE in 1 CARTON (35573-430-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35573-430-30 [35573043030]

Abacavir and Lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090159
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-15

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE600 mg/1

Pharmacological Class

  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Nucleoside Analog [EXT]
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]
  • 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]
  • 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 "Abacavir and Lamivudine" or generic name "Abacavir And Lamivudine"

NDCBrand NameGeneric Name
0093-5382Abacavir and LamivudineAbacavir and Lamivudine
35573-402Abacavir and LamivudineAbacavir and Lamivudine
35573-430Abacavir and LamivudineAbacavir and Lamivudine
42291-115Abacavir and LamivudineAbacavir and Lamivudine
42385-962Abacavir and LamivudineAbacavir and Lamivudine
65862-335Abacavir and LamivudineAbacavir and Lamivudine
65862-900Abacavir and LamivudineAbacavir and Lamivudine
66993-482Abacavir and Lamivudineabacavir sulfate and lamivudine
68180-288Abacavir and LamivudineAbacavir and Lamivudine
69097-362Abacavir and LamivudineAbacavir and lamivudine
70518-0715Abacavir and LamivudineAbacavir and Lamivudine
70710-1049Abacavir and lamivudineAbacavir and lamivudine
70771-1053Abacavir and lamivudineAbacavir and lamivudine
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.