acyclovir

Generic: acyclovir

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

Drug Facts

Product Profile

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

acyclovir 400 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-050
Product ID 76420-050_b01ced44-7b5d-5716-e053-2995a90a1263
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077309
Listing Expiration 2026-12-31
Marketing Start 2007-06-09

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 76420050
Hyphenated Format 76420-050

Supplemental Identifiers

RxCUI
197311
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 ANDA077309 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (76420-050-15)
  • 30 TABLET in 1 BOTTLE (76420-050-30)
  • 60 TABLET in 1 BOTTLE (76420-050-60)
source: ndc

Packages (3)

76420-050-15 15 TABLET in 1 BOTTLE (76420-050-15) 76420-050-30 30 TABLET in 1 BOTTLE (76420-050-30) 76420-050-60 60 TABLET in 1 BOTTLE (76420-050-60)

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": "b01ced44-7b5d-5716-e053-2995a90a1263", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["197311"], "spl_set_id": ["e186fdc9-b60e-4280-8d60-36cae9f2838f"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (76420-050-15)", "package_ndc": "76420-050-15", "marketing_start_date": "20200925"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-050-30)", "package_ndc": "76420-050-30", "marketing_start_date": "20200925"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-050-60)", "package_ndc": "76420-050-60", "marketing_start_date": "20200925"}], "brand_name": "acyclovir", "product_id": "76420-050_b01ced44-7b5d-5716-e053-2995a90a1263", "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": "76420-050", "generic_name": "acyclovir", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "400 mg/1"}], "application_number": "ANDA077309", "marketing_category": "ANDA", "marketing_start_date": "20070609", "listing_expiration_date": "20261231"}