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 400 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-928
Product ID 43063-928_415e6410-928c-0b21-e063-6294a90a183c
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 43063928
Hyphenated Format 43063-928

Supplemental Identifiers

RxCUI
197311
UPC
0343063928301
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
  • 400 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE, PLASTIC (43063-928-04)
  • 5 TABLET in 1 BOTTLE, PLASTIC (43063-928-05)
  • 15 TABLET in 1 BOTTLE, PLASTIC (43063-928-15)
  • 25 TABLET in 1 BOTTLE, PLASTIC (43063-928-25)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-928-30)
  • 40 TABLET in 1 BOTTLE, PLASTIC (43063-928-40)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-928-60)
source: ndc

Packages (7)

Ingredients (1)

acyclovir (400 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "415e6410-928c-0b21-e063-6294a90a183c", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0343063928301"], "unii": ["X4HES1O11F"], "rxcui": ["197311"], "spl_set_id": ["db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0"], "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": "4 TABLET in 1 BOTTLE, PLASTIC (43063-928-04)", "package_ndc": "43063-928-04", "marketing_start_date": "20200618"}, {"sample": false, "description": "5 TABLET in 1 BOTTLE, PLASTIC (43063-928-05)", "package_ndc": "43063-928-05", "marketing_start_date": "20231030"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (43063-928-15)", "package_ndc": "43063-928-15", "marketing_start_date": "20190213"}, {"sample": false, "description": "25 TABLET in 1 BOTTLE, PLASTIC (43063-928-25)", "package_ndc": "43063-928-25", "marketing_start_date": "20190125"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-928-30)", "package_ndc": "43063-928-30", "marketing_start_date": "20190116"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE, PLASTIC (43063-928-40)", "package_ndc": "43063-928-40", "marketing_start_date": "20190329"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-928-60)", "package_ndc": "43063-928-60", "marketing_start_date": "20190109"}], "brand_name": "Acyclovir", "product_id": "43063-928_415e6410-928c-0b21-e063-6294a90a183c", "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": "43063-928", "generic_name": "Acyclovir", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "400 mg/1"}], "application_number": "ANDA203834", "marketing_category": "ANDA", "marketing_start_date": "20131129", "listing_expiration_date": "20261231"}