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 CAPSULE
Routes
ORAL
Active Ingredients

acyclovir 200 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-124
Product ID 75834-124_bdd7c1ab-7f2d-43b5-9ff7-238aa1b9576f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201445
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 75834124
Hyphenated Format 75834-124

Supplemental Identifiers

RxCUI
197310
UPC
0375834124018
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 ANDA201445 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (75834-124-01)
  • 500 CAPSULE in 1 BOTTLE (75834-124-05)
source: ndc

Packages (2)

75834-124-01 100 CAPSULE in 1 BOTTLE (75834-124-01) 75834-124-05 500 CAPSULE in 1 BOTTLE (75834-124-05)

Ingredients (1)

acyclovir (200 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": "bdd7c1ab-7f2d-43b5-9ff7-238aa1b9576f", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0375834124018"], "unii": ["X4HES1O11F"], "rxcui": ["197310"], "spl_set_id": ["1b0919aa-0d41-4c91-9ef4-049ac9e27d78"], "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 CAPSULE in 1 BOTTLE (75834-124-01)", "package_ndc": "75834-124-01", "marketing_start_date": "20161015"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (75834-124-05)", "package_ndc": "75834-124-05", "marketing_start_date": "20161015"}], "brand_name": "Acyclovir", "product_id": "75834-124_bdd7c1ab-7f2d-43b5-9ff7-238aa1b9576f", "dosage_form": "CAPSULE", "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": "75834-124", "generic_name": "Acyclovir", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "200 mg/1"}], "application_number": "ANDA201445", "marketing_category": "ANDA", "marketing_start_date": "20161015", "listing_expiration_date": "20261231"}