acyclovir

Generic: acyclovir

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acyclovir 800 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-123
Product ID 75834-123_d14fe0b4-4772-45ee-b0d9-6ea50e5c9733
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202168
Listing Expiration 2026-12-31
Marketing Start 2016-10-15

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 75834123
Hyphenated Format 75834-123

Supplemental Identifiers

RxCUI
197311 197313
UPC
0375834122014 0375834123011
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 ANDA202168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (75834-123-01)
  • 500 TABLET in 1 BOTTLE (75834-123-05)
source: ndc

Packages (2)

75834-123-01 100 TABLET in 1 BOTTLE (75834-123-01) 75834-123-05 500 TABLET in 1 BOTTLE (75834-123-05)

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": "d14fe0b4-4772-45ee-b0d9-6ea50e5c9733", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0375834122014", "0375834123011"], "unii": ["X4HES1O11F"], "rxcui": ["197311", "197313"], "spl_set_id": ["7e83897b-9662-4f69-860e-da357800fc55"], "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": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-123-01)", "package_ndc": "75834-123-01", "marketing_start_date": "20161015"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (75834-123-05)", "package_ndc": "75834-123-05", "marketing_start_date": "20161015"}], "brand_name": "Acyclovir", "product_id": "75834-123_d14fe0b4-4772-45ee-b0d9-6ea50e5c9733", "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": "75834-123", "generic_name": "Acyclovir", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "800 mg/1"}], "application_number": "ANDA202168", "marketing_category": "ANDA", "marketing_start_date": "20161015", "listing_expiration_date": "20261231"}