acyclovir

Generic: acyclovir

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler macleods pharmaceuticals limited
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

acyclovir 50 mg/g

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-439
Product ID 33342-439_49a1e24d-5821-45a5-bf2f-0497f4fd3a1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212444
Listing Expiration 2026-12-31
Marketing Start 2018-08-13

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 33342439
Hyphenated Format 33342-439

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 ANDA212444 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (33342-439-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (33342-439-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

33342-439-15 1 TUBE in 1 CARTON (33342-439-15) / 15 g in 1 TUBE 33342-439-30 1 TUBE in 1 CARTON (33342-439-30) / 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": "49a1e24d-5821-45a5-bf2f-0497f4fd3a1b", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["197312"], "spl_set_id": ["d42fce5a-9ea3-4058-a3ba-4c18a6024160"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (33342-439-15)  / 15 g in 1 TUBE", "package_ndc": "33342-439-15", "marketing_start_date": "20210805"}, {"sample": false, "description": "1 TUBE in 1 CARTON (33342-439-30)  / 30 g in 1 TUBE", "package_ndc": "33342-439-30", "marketing_start_date": "20180813"}], "brand_name": "Acyclovir", "product_id": "33342-439_49a1e24d-5821-45a5-bf2f-0497f4fd3a1b", "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": "33342-439", "generic_name": "Acyclovir", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "50 mg/g"}], "application_number": "ANDA212444", "marketing_category": "ANDA", "marketing_start_date": "20180813", "listing_expiration_date": "20261231"}