acyclovir

Generic: acyclovir

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acyclovir sodium 50 mg/mL

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-048
Product ID 68382-048_515388e8-636f-42f6-a39e-bb4fc7c2e7cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206535
Listing Expiration 2026-12-31
Marketing Start 2018-11-27

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 68382048
Hyphenated Format 68382-048

Supplemental Identifiers

RxCUI
1734932 1734934
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 ANDA206535 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (68382-048-10) / 10 mL in 1 VIAL, SINGLE-USE (68382-048-01)
source: ndc

Packages (1)

68382-048-10 10 VIAL, SINGLE-USE in 1 CARTON (68382-048-10) / 10 mL in 1 VIAL, SINGLE-USE (68382-048-01)

Ingredients (1)

acyclovir sodium (50 mg/mL)

Linked Drug Pages (1)

acyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "515388e8-636f-42f6-a39e-bb4fc7c2e7cb", "openfda": {"unii": ["927L42J563"], "rxcui": ["1734932", "1734934"], "spl_set_id": ["69a98000-adef-4323-89a7-09e035a257d4"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (68382-048-10)  / 10 mL in 1 VIAL, SINGLE-USE (68382-048-01)", "package_ndc": "68382-048-10", "marketing_start_date": "20181127"}], "brand_name": "acyclovir", "product_id": "68382-048_515388e8-636f-42f6-a39e-bb4fc7c2e7cb", "dosage_form": "INJECTION, 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": "68382-048", "generic_name": "ACYCLOVIR", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acyclovir", "active_ingredients": [{"name": "ACYCLOVIR SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA206535", "marketing_category": "ANDA", "marketing_start_date": "20181127", "listing_expiration_date": "20261231"}