acyclovir

Generic: acyclovir

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler ani pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acyclovir 200 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-188
Product ID 70954-188_87d55aa5-78a8-458e-9a82-f4f36d9d1c9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212252
Listing Expiration 2027-12-31
Marketing Start 2020-07-13

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 70954188
Hyphenated Format 70954-188

Supplemental Identifiers

RxCUI
307730
UPC
0370954188100
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 ANDA212252 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (70954-188-10)
source: ndc

Packages (1)

70954-188-10 473 mL in 1 BOTTLE (70954-188-10)

Ingredients (1)

acyclovir (200 mg/5mL)

Linked Drug Pages (1)

acyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "87d55aa5-78a8-458e-9a82-f4f36d9d1c9b", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "upc": ["0370954188100"], "unii": ["X4HES1O11F"], "rxcui": ["307730"], "spl_set_id": ["8208711c-18ba-4615-b932-3c0bb7e6efae"], "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": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (70954-188-10)", "package_ndc": "70954-188-10", "marketing_start_date": "20200713"}], "brand_name": "acyclovir", "product_id": "70954-188_87d55aa5-78a8-458e-9a82-f4f36d9d1c9b", "dosage_form": "SUSPENSION", "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": "70954-188", "generic_name": "acyclovir", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "200 mg/5mL"}], "application_number": "ANDA212252", "marketing_category": "ANDA", "marketing_start_date": "20200713", "listing_expiration_date": "20271231"}