acyclovir

Generic: acyclovir

Labeler: square pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler square pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 400 mg/1

Manufacturer
SQUARE PHARMACEUTICALS LIMITED

Identifiers & Regulatory

Product NDC 76483-047
Product ID 76483-047_2b705cc7-7286-4acb-a3e7-95c65fc90bc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209366
Listing Expiration 2026-12-31
Marketing Start 2020-01-31

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 76483047
Hyphenated Format 76483-047

Supplemental Identifiers

RxCUI
197311 197313
UNII
X4HES1O11F
NUI
N0000020060 N0000180187 N0000180188 N0000175468 N0000175459

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 ANDA209366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (76483-047-00)
  • 100 TABLET in 1 BOTTLE (76483-047-04)
  • 500 TABLET in 1 BOTTLE (76483-047-05)
source: ndc

Packages (3)

76483-047-00 30 TABLET in 1 BOTTLE (76483-047-00) 76483-047-04 100 TABLET in 1 BOTTLE (76483-047-04) 76483-047-05 500 TABLET in 1 BOTTLE (76483-047-05)

Ingredients (1)

acyclovir (400 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": "2b705cc7-7286-4acb-a3e7-95c65fc90bc3", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["197311", "197313"], "spl_set_id": ["b24201ea-aeae-4de1-b01b-eee89068e786"], "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": ["SQUARE PHARMACEUTICALS LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (76483-047-00)", "package_ndc": "76483-047-00", "marketing_start_date": "20200131"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (76483-047-04)", "package_ndc": "76483-047-04", "marketing_start_date": "20200131"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76483-047-05)", "package_ndc": "76483-047-05", "marketing_start_date": "20200131"}], "brand_name": "Acyclovir", "product_id": "76483-047_2b705cc7-7286-4acb-a3e7-95c65fc90bc3", "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": "76483-047", "generic_name": "Acyclovir", "labeler_name": "SQUARE PHARMACEUTICALS LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "400 mg/1"}], "application_number": "ANDA209366", "marketing_category": "ANDA", "marketing_start_date": "20200131", "listing_expiration_date": "20261231"}