acyclovir

Generic: acyclovir

Labeler: pharmpak, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 800 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-624
Product ID 54348-624_ea935f93-6c2c-2e8a-e053-2995a90a2ce0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203834
Listing Expiration 2026-12-31
Marketing Start 2019-07-09

Pharmacologic Class

Established (EPC)
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]
Mechanism of Action
dna polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348624
Hyphenated Format 54348-624

Supplemental Identifiers

RxCUI
197313
UNII
X4HES1O11F
NUI
N0000020060 N0000180187 N0000180188 N0000175468 N0000175459

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 ANDA203834 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-624-10) / 10 TABLET in 1 BOTTLE
source: ndc

Packages (1)

54348-624-10 1 BOTTLE in 1 BOX (54348-624-10) / 10 TABLET in 1 BOTTLE

Ingredients (1)

acyclovir (800 mg/1)

Linked Drug Pages (1)

Acyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea935f93-6c2c-2e8a-e053-2995a90a2ce0", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["197313"], "spl_set_id": ["d824fc07-9f03-4cb2-9bf8-ff7cc2955255"], "pharm_class_epc": ["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]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-624-10)  / 10 TABLET in 1 BOTTLE", "package_ndc": "54348-624-10", "marketing_start_date": "20190709"}], "brand_name": "Acyclovir", "product_id": "54348-624_ea935f93-6c2c-2e8a-e053-2995a90a2ce0", "dosage_form": "TABLET", "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": "54348-624", "generic_name": "ACYCLOVIR", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "800 mg/1"}], "application_number": "ANDA203834", "marketing_category": "ANDA", "marketing_start_date": "20190709", "listing_expiration_date": "20261231"}