acyclovir

Generic: acyclovir

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

Drug Facts

Product Profile

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

acyclovir 50 mg/g

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-515
Product ID 13668-515_95f260b9-dd7f-4bd5-af7e-c4f4671ac6bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209971
Listing Expiration 2026-12-31
Marketing Start 2019-01-11

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 13668515
Hyphenated Format 13668-515

Supplemental Identifiers

RxCUI
197312
UPC
0313668515015
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 ANDA209971 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (13668-515-01)
  • 30 g in 1 TUBE (13668-515-02)
source: ndc

Packages (2)

13668-515-01 15 g in 1 TUBE (13668-515-01) 13668-515-02 30 g in 1 TUBE (13668-515-02)

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": "95f260b9-dd7f-4bd5-af7e-c4f4671ac6bd", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0313668515015"], "unii": ["X4HES1O11F"], "rxcui": ["197312"], "spl_set_id": ["1c510390-fb00-4271-967d-0883a9d5e1fd"], "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": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (13668-515-01)", "package_ndc": "13668-515-01", "marketing_start_date": "20190111"}, {"sample": false, "description": "30 g in 1 TUBE (13668-515-02)", "package_ndc": "13668-515-02", "marketing_start_date": "20190111"}], "brand_name": "acyclovir", "product_id": "13668-515_95f260b9-dd7f-4bd5-af7e-c4f4671ac6bd", "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": "13668-515", "generic_name": "acyclovir", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "50 mg/g"}], "application_number": "ANDA209971", "marketing_category": "ANDA", "marketing_start_date": "20190111", "listing_expiration_date": "20261231"}