acyclovir

Generic: acyclovir

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler solco healthcare us, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

acyclovir 50 mg/g

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-499
Product ID 43547-499_a1d7b8ec-309d-447e-ae05-b9e89cc29948
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212202
Listing Expiration 2026-12-31
Marketing Start 2021-11-15

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 43547499
Hyphenated Format 43547-499

Supplemental Identifiers

RxCUI
197312
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 ANDA212202 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (43547-499-41) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (43547-499-42) / 15 g in 1 TUBE
source: ndc

Packages (2)

43547-499-41 1 TUBE in 1 CARTON (43547-499-41) / 30 g in 1 TUBE 43547-499-42 1 TUBE in 1 CARTON (43547-499-42) / 15 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": "a1d7b8ec-309d-447e-ae05-b9e89cc29948", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["197312"], "spl_set_id": ["a1d7b8ec-309d-447e-ae05-b9e89cc29948"], "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": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (43547-499-41)  / 30 g in 1 TUBE", "package_ndc": "43547-499-41", "marketing_start_date": "20211115"}, {"sample": false, "description": "1 TUBE in 1 CARTON (43547-499-42)  / 15 g in 1 TUBE", "package_ndc": "43547-499-42", "marketing_start_date": "20211115"}], "brand_name": "ACYCLOVIR", "product_id": "43547-499_a1d7b8ec-309d-447e-ae05-b9e89cc29948", "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": "43547-499", "generic_name": "acyclovir", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACYCLOVIR", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "50 mg/g"}], "application_number": "ANDA212202", "marketing_category": "ANDA", "marketing_start_date": "20211115", "listing_expiration_date": "20261231"}