FDA Orange Book · active-ingredient family
Acyclovir sodium
Acyclovir sodium: 1 brand, 21 generics; first approved Oct 22, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
21
Listed patents
0
Presentations
34
Brand (NDA) products
Originator applications
- ZOVIRAXRLDGLAXOSMITHKLINENDA 01860319893 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (21)
Abbreviated applications
- ACYCLOVIR SODIUMFRESENIUS KABI USAANDA 2154042024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP - ACYCLOVIR SODIUMSLATE RUN PHARMAANDA 2181112024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP - ACYCLOVIR SODIUMDR REDDYSANDA 2079192020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMZYDUS PHARMSANDA 2065352018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP - ACYCLOVIR SODIUMZYDUS PHARMSANDA 20660620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMPHARMOBEDIENTANDA 20392720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMHIKMAANDA 20577120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMEUGIA PHARMAANDA 2037012013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP - ACYCLOVIR SODIUMTEVA PARENTERALANDA 0756272001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued — - ABBVIEANDA 0751141999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMHOSPIRAANDA 0750651999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMRSFRESENIUS KABI USAANDA 0749301998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP - ACYCLOVIR SODIUMFRESENIUS KABI USAANDA 0750151998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMAPOTHECONANDA 07489719982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - EUROHLTH INTL SARLANDA 07488519972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMEUROHLTH INTL SARLANDA 07491319972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMTEVA PARENTERALANDA 07496919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMCHARTWELL INJECTABLEANDA 07459619972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMHOSPIRAANDA 07466319972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMHOSPIRAANDA 07475819972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ACYCLOVIR SODIUMHOSPIRAANDA 0747201997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
44 yr 6 mo ago
Most recent approval
2 yr 2 mo ago
Approvals span 1982–2024 across 22 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 2195%
Acyclovir sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
