acyclovir

Generic: acyclovir

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 400 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-061
Product ID 50268-061_47e22393-03a9-791e-e063-6294a90aa89a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075382
Listing Expiration 2027-12-31
Marketing Start 2011-03-16

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 50268061
Hyphenated Format 50268-061

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50268-061-15) / 1 TABLET in 1 BLISTER PACK (50268-061-11)
source: ndc

Packages (1)

50268-061-15 50 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50268-061-15) / 1 TABLET in 1 BLISTER PACK (50268-061-11)

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": "47e22393-03a9-791e-e063-6294a90aa89a", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["197311", "197313"], "spl_set_id": ["6e203fa9-ee97-1e08-8d6a-fb57cfa13e19"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50268-061-15)  / 1 TABLET in 1 BLISTER PACK (50268-061-11)", "package_ndc": "50268-061-15", "marketing_start_date": "20110316"}], "brand_name": "Acyclovir", "product_id": "50268-061_47e22393-03a9-791e-e063-6294a90aa89a", "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": "50268-061", "generic_name": "Acyclovir", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "400 mg/1"}], "application_number": "ANDA075382", "marketing_category": "ANDA", "marketing_start_date": "20110316", "listing_expiration_date": "20271231"}