acyclovir

Generic: acyclovir

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 800 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-138
Product ID 69367-138_12e91d37-d793-4a08-9455-fefe6eb0d2c7
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 69367138
Hyphenated Format 69367-138

Supplemental Identifiers

RxCUI
197311 197313
UPC
0369367137010 0369367138017
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 ANDA210401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69367-138-01)
  • 500 TABLET in 1 BOTTLE (69367-138-05)
source: ndc

Packages (2)

69367-138-01 100 TABLET in 1 BOTTLE (69367-138-01) 69367-138-05 500 TABLET in 1 BOTTLE (69367-138-05)

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": "12e91d37-d793-4a08-9455-fefe6eb0d2c7", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0369367137010", "0369367138017"], "unii": ["X4HES1O11F"], "rxcui": ["197311", "197313"], "spl_set_id": ["f352a641-988e-4878-8016-2b69cd6ee548"], "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": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69367-138-01)", "package_ndc": "69367-138-01", "marketing_start_date": "20230620"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69367-138-05)", "package_ndc": "69367-138-05", "marketing_start_date": "20230620"}], "brand_name": "Acyclovir", "product_id": "69367-138_12e91d37-d793-4a08-9455-fefe6eb0d2c7", "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": "69367-138", "generic_name": "Acyclovir", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "800 mg/1"}], "application_number": "ANDA210401", "marketing_category": "ANDA", "marketing_start_date": "20230620", "listing_expiration_date": "20261231"}