NDC 50268-049

Abacavir

Abacavir

Abacavir is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Abacavir Sulfate.

Product ID50268-049_a2f05bba-8583-3c02-e053-2a95a90a65d1
NDC50268-049
Product TypeHuman Prescription Drug
Proprietary NameAbacavir
Generic NameAbacavir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-04-10
Marketing CategoryANDA / ANDA
Application NumberANDA091560
Labeler NameAvPAK
Substance NameABACAVIR SULFATE
Active Ingredient Strength300 mg/1
Pharm ClassesHuman 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 50268-049-12

20 BLISTER PACK in 1 BOX (50268-049-12) > 1 TABLET in 1 BLISTER PACK (50268-049-11)
Marketing Start Date2020-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-049-11 [50268004911]

Abacavir TABLET
Marketing CategoryANDA
Application NumberANDA091560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-10

NDC 50268-049-12 [50268004912]

Abacavir TABLET
Marketing CategoryANDA
Application NumberANDA091560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-10

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE300 mg/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0121-0897AbacavirAbacavir
0904-6874AbacavirAbacavir
31722-557AbacavirAbacavir
31722-562AbacavirAbacavir
50268-049AbacavirAbacavir
64380-717AbacavirAbacavir
64980-405AbacavirAbacavir Sulfate
65862-073AbacavirAbacavir
65862-089AbacavirAbacavir Sulfate
68084-021AbacavirAbacavir Sulfate
69097-514AbacavirAbacavir
70518-0559AbacavirAbacavir
70518-1274AbacavirAbacavir
72865-167AbacavirAbacavir

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