acyclovir

Generic: acyclovir

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 400 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-965
Product ID 59651-965_41cc963e-4d7b-49bd-b281-d5aaa9133026
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075211
Listing Expiration 2026-12-31
Marketing Start 2025-09-11

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 59651965
Hyphenated Format 59651-965

Supplemental Identifiers

RxCUI
197311 197313
UPC
0359651965016
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 ANDA075211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-965-01)
  • 500 TABLET in 1 BOTTLE (59651-965-05)
  • 10 TABLET in 1 BOTTLE (59651-965-10)
source: ndc

Packages (3)

Ingredients (1)

acyclovir (400 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "41cc963e-4d7b-49bd-b281-d5aaa9133026", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0359651965016"], "unii": ["X4HES1O11F"], "rxcui": ["197311", "197313"], "spl_set_id": ["cfee4476-a3c9-4e0c-a235-c68c5d46931e"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-965-01)", "package_ndc": "59651-965-01", "marketing_start_date": "20250911"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (59651-965-05)", "package_ndc": "59651-965-05", "marketing_start_date": "20250911"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (59651-965-10)", "package_ndc": "59651-965-10", "marketing_start_date": "20250911"}], "brand_name": "ACYCLOVIR", "product_id": "59651-965_41cc963e-4d7b-49bd-b281-d5aaa9133026", "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": "59651-965", "generic_name": "ACYCLOVIR", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACYCLOVIR", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "400 mg/1"}], "application_number": "ANDA075211", "marketing_category": "ANDA", "marketing_start_date": "20250911", "listing_expiration_date": "20261231"}