acyclovir

Generic: acyclovir

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 800 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-589
Product ID 43063-589_4139742d-d092-121c-e063-6394a90a6221
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203834
Listing Expiration 2026-12-31
Marketing Start 2013-11-29

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 43063589
Hyphenated Format 43063-589

Supplemental Identifiers

RxCUI
197313
UPC
0343063589359
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
  • 10 TABLET in 1 BOTTLE, PLASTIC (43063-589-10)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-589-30)
  • 35 TABLET in 1 BOTTLE, PLASTIC (43063-589-35)
  • 50 TABLET in 1 BOTTLE, PLASTIC (43063-589-50)
source: ndc

Packages (4)

43063-589-10 10 TABLET in 1 BOTTLE, PLASTIC (43063-589-10) 43063-589-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-589-30) 43063-589-35 35 TABLET in 1 BOTTLE, PLASTIC (43063-589-35) 43063-589-50 50 TABLET in 1 BOTTLE, PLASTIC (43063-589-50)

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": "4139742d-d092-121c-e063-6394a90a6221", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0343063589359"], "unii": ["X4HES1O11F"], "rxcui": ["197313"], "spl_set_id": ["e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (43063-589-10)", "package_ndc": "43063-589-10", "marketing_start_date": "20160804"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-589-30)", "package_ndc": "43063-589-30", "marketing_start_date": "20150929"}, {"sample": false, "description": "35 TABLET in 1 BOTTLE, PLASTIC (43063-589-35)", "package_ndc": "43063-589-35", "marketing_start_date": "20150806"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (43063-589-50)", "package_ndc": "43063-589-50", "marketing_start_date": "20150911"}], "brand_name": "Acyclovir", "product_id": "43063-589_4139742d-d092-121c-e063-6394a90a6221", "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": "43063-589", "generic_name": "Acyclovir", "labeler_name": "PD-Rx Pharmaceuticals, 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": "20131129", "listing_expiration_date": "20261231"}