acyclovir

Generic: acyclovir

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acyclovir sodium 500 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9657
Product ID 0143-9657_dbf69540-34d6-423d-a06a-e5eddfd40ae3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205771
Listing Expiration 2026-12-31
Marketing Start 2016-02-29

Pharmacologic Class

Classes
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439657
Hyphenated Format 0143-9657

Supplemental Identifiers

RxCUI
2263503 2263505
UNII
927L42J563

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 ANDA205771 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01)
source: ndc

Packages (1)

0143-9657-10 10 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01)

Ingredients (1)

acyclovir sodium (500 mg/1)

Linked Drug Pages (1)

Acyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "dbf69540-34d6-423d-a06a-e5eddfd40ae3", "openfda": {"unii": ["927L42J563"], "rxcui": ["2263503", "2263505"], "spl_set_id": ["babdbce2-5cbd-4943-bc38-9ebdd696a77a"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01)", "package_ndc": "0143-9657-10", "marketing_start_date": "20160229"}], "brand_name": "Acyclovir", "product_id": "0143-9657_dbf69540-34d6-423d-a06a-e5eddfd40ae3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "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": "0143-9657", "generic_name": "Acyclovir", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA205771", "marketing_category": "ANDA", "marketing_start_date": "20160229", "listing_expiration_date": "20261231"}