acyclovir

Generic: acyclovir

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 400 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-005
Product ID 82804-005_2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210401
Listing Expiration 2026-12-31
Marketing Start 2023-06-20

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 82804005
Hyphenated Format 82804-005

Supplemental Identifiers

RxCUI
197311
UPC
0382804005307
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 ANDA210401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BOTTLE (82804-005-06)
  • 15 TABLET in 1 BOTTLE (82804-005-15)
  • 20 TABLET in 1 BOTTLE (82804-005-20)
  • 21 TABLET in 1 BOTTLE (82804-005-21)
  • 30 TABLET in 1 BOTTLE (82804-005-30)
  • 35 TABLET in 1 BOTTLE (82804-005-35)
  • 60 TABLET in 1 BOTTLE (82804-005-60)
  • 90 TABLET in 1 BOTTLE (82804-005-90)
source: ndc

Packages (8)

82804-005-06 6 TABLET in 1 BOTTLE (82804-005-06) 82804-005-15 15 TABLET in 1 BOTTLE (82804-005-15) 82804-005-20 20 TABLET in 1 BOTTLE (82804-005-20) 82804-005-21 21 TABLET in 1 BOTTLE (82804-005-21) 82804-005-30 30 TABLET in 1 BOTTLE (82804-005-30) 82804-005-35 35 TABLET in 1 BOTTLE (82804-005-35) 82804-005-60 60 TABLET in 1 BOTTLE (82804-005-60) 82804-005-90 90 TABLET in 1 BOTTLE (82804-005-90)

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": "2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0382804005307"], "unii": ["X4HES1O11F"], "rxcui": ["197311"], "spl_set_id": ["97ed8713-4b3e-48a9-92c0-0a98ecf0485c"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE (82804-005-06)", "package_ndc": "82804-005-06", "marketing_start_date": "20240109"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (82804-005-15)", "package_ndc": "82804-005-15", "marketing_start_date": "20240109"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (82804-005-20)", "package_ndc": "82804-005-20", "marketing_start_date": "20240109"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (82804-005-21)", "package_ndc": "82804-005-21", "marketing_start_date": "20240109"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-005-30)", "package_ndc": "82804-005-30", "marketing_start_date": "20230831"}, {"sample": false, "description": "35 TABLET in 1 BOTTLE (82804-005-35)", "package_ndc": "82804-005-35", "marketing_start_date": "20240109"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-005-60)", "package_ndc": "82804-005-60", "marketing_start_date": "20230831"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-005-90)", "package_ndc": "82804-005-90", "marketing_start_date": "20230831"}], "brand_name": "Acyclovir", "product_id": "82804-005_2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c", "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": "82804-005", "generic_name": "Acyclovir", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "400 mg/1"}], "application_number": "ANDA210401", "marketing_category": "ANDA", "marketing_start_date": "20230620", "listing_expiration_date": "20261231"}