NDC 0121-0897

Abacavir

Abacavir

Abacavir is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Abacavir Sulfate.

Product ID0121-0897_ac38acc1-cc0b-9467-e053-2995a90adf11
NDC0121-0897
Product TypeHuman Prescription Drug
Proprietary NameAbacavir
Generic NameAbacavir
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2020-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA201107
Labeler NamePharmaceutical Associates, Inc.
Substance NameABACAVIR SULFATE
Active Ingredient Strength20 mg/mL
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 0121-0897-20

10 TRAY in 1 CASE (0121-0897-20) > 10 CUP, UNIT-DOSE in 1 TRAY > 1 mL in 1 CUP, UNIT-DOSE (0121-0897-15)
Marketing Start Date2020-08-20
NDC Exclude FlagN
Sample Package?N

Drug Details

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.