acyclovir

Generic: acyclovir

Labeler: carlsbad technology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler carlsbad technology, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 800 mg/1

Manufacturer
Carlsbad Technology, Inc.

Identifiers & Regulatory

Product NDC 61442-113
Product ID 61442-113_209d3251-8d40-86dc-e063-6394a90a3492
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075382
Listing Expiration 2026-12-31
Marketing Start 2009-10-22

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 61442113
Hyphenated Format 61442-113

Supplemental Identifiers

RxCUI
197311 197313
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 ANDA075382 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 24 BOTTLE, PLASTIC in 1 BOX (61442-113-01) / 100 TABLET in 1 BOTTLE, PLASTIC
  • 12 BOTTLE, PLASTIC in 1 BOX (61442-113-05) / 500 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

61442-113-01 24 BOTTLE, PLASTIC in 1 BOX (61442-113-01) / 100 TABLET in 1 BOTTLE, PLASTIC 61442-113-05 12 BOTTLE, PLASTIC in 1 BOX (61442-113-05) / 500 TABLET in 1 BOTTLE, PLASTIC

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": "209d3251-8d40-86dc-e063-6394a90a3492", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["197311", "197313"], "spl_set_id": ["a68e610a-841c-4b69-9233-673d060561e8"], "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": ["Carlsbad Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BOTTLE, PLASTIC in 1 BOX (61442-113-01)  / 100 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "61442-113-01", "marketing_start_date": "20200124"}, {"sample": false, "description": "12 BOTTLE, PLASTIC in 1 BOX (61442-113-05)  / 500 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "61442-113-05", "marketing_start_date": "20200124"}], "brand_name": "Acyclovir", "product_id": "61442-113_209d3251-8d40-86dc-e063-6394a90a3492", "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": "61442-113", "generic_name": "Acyclovir", "labeler_name": "Carlsbad Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "800 mg/1"}], "application_number": "ANDA075382", "marketing_category": "ANDA", "marketing_start_date": "20091022", "listing_expiration_date": "20261231"}