acyclovir

Generic: acyclovir

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acyclovir sodium 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-624
Product ID 65219-624_a2fee863-ed62-4501-881d-eab609ebd51d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215404
Listing Expiration 2026-12-31
Marketing Start 2024-12-16

Pharmacologic Class

Classes
dna polymerase inhibitors [moa] herpes simplex virus nucleoside analog dna polymerase inhibitor [epc] herpes zoster virus nucleoside analog dna polymerase inhibitor [epc] herpesvirus nucleoside analog dna polymerase inhibitor [epc] nucleoside analog [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219624
Hyphenated Format 65219-624

Supplemental Identifiers

RxCUI
1734932 1734934
UPC
0365219622024 0365219624042
UNII
927L42J563

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acyclovir (source: ndc)
Generic Name acyclovir (source: ndc)
Application Number ANDA215404 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (65219-624-20) / 20 mL in 1 VIAL (65219-624-04)
source: ndc

Packages (1)

65219-624-20 10 VIAL in 1 CARTON (65219-624-20) / 20 mL in 1 VIAL (65219-624-04)

Ingredients (1)

acyclovir sodium (50 mg/mL)

Linked Drug Pages (1)

acyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a2fee863-ed62-4501-881d-eab609ebd51d", "openfda": {"upc": ["0365219622024", "0365219624042"], "unii": ["927L42J563"], "rxcui": ["1734932", "1734934"], "spl_set_id": ["b1bb347d-74f4-4976-8450-a375a271718f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (65219-624-20)  / 20 mL in 1 VIAL (65219-624-04)", "package_ndc": "65219-624-20", "marketing_start_date": "20241216"}], "brand_name": "acyclovir", "product_id": "65219-624_a2fee863-ed62-4501-881d-eab609ebd51d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "65219-624", "generic_name": "ACYCLOVIR", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acyclovir", "active_ingredients": [{"name": "ACYCLOVIR SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA215404", "marketing_category": "ANDA", "marketing_start_date": "20241216", "listing_expiration_date": "20261231"}