acyclovir

Generic: acyclovir

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler amneal pharmaceuticals llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

acyclovir 50 mg/g

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-835
Product ID 65162-835_5701d6c5-b948-4d7b-ab6e-99b5c559dbf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204605
Listing Expiration 2026-12-31
Marketing Start 2014-01-03

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 65162835
Hyphenated Format 65162-835

Supplemental Identifiers

RxCUI
197312
UPC
0365162835946 0365162835960
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 ANDA204605 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE
source: ndc

Packages (2)

65162-835-94 1 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE 65162-835-96 1 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE

Ingredients (1)

acyclovir (50 mg/g)

Linked Drug Pages (1)

Acyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "5701d6c5-b948-4d7b-ab6e-99b5c559dbf5", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0365162835946", "0365162835960"], "unii": ["X4HES1O11F"], "rxcui": ["197312"], "spl_set_id": ["269e2203-347d-40dc-b794-11cf34690f27"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (65162-835-94)  / 15 g in 1 TUBE", "package_ndc": "65162-835-94", "marketing_start_date": "20140103"}, {"sample": false, "description": "1 TUBE in 1 CARTON (65162-835-96)  / 30 g in 1 TUBE", "package_ndc": "65162-835-96", "marketing_start_date": "20140103"}], "brand_name": "Acyclovir", "product_id": "65162-835_5701d6c5-b948-4d7b-ab6e-99b5c559dbf5", "dosage_form": "OINTMENT", "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": "65162-835", "generic_name": "Acyclovir", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "50 mg/g"}], "application_number": "ANDA204605", "marketing_category": "ANDA", "marketing_start_date": "20140103", "listing_expiration_date": "20261231"}