acyclovir

Generic: acyclovir

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acyclovir
Generic Name acyclovir
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acyclovir 200 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-803
Product ID 68999-803_46a3a089-45f8-184c-e063-6294a90a9bc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212718
Listing Expiration 2026-12-31
Marketing Start 2020-04-23

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 68999803
Hyphenated Format 68999-803

Supplemental Identifiers

RxCUI
307730
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 ANDA212718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-803-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-803-20)
  • 2 TRAY in 1 BOX (68999-803-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-803-05)
source: ndc

Packages (2)

Ingredients (1)

acyclovir (200 mg/5mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "46a3a089-45f8-184c-e063-6294a90a9bc4", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000180188", "N0000175468", "N0000175459"], "unii": ["X4HES1O11F"], "rxcui": ["307730"], "spl_set_id": ["2757bb30-3374-4e1b-b496-14874f7ec623"], "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": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-803-23)  / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-803-20)", "package_ndc": "68999-803-23", "marketing_start_date": "20251219"}, {"sample": false, "description": "2 TRAY in 1 BOX (68999-803-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-803-05)", "package_ndc": "68999-803-24", "marketing_start_date": "20251219"}], "brand_name": "Acyclovir", "product_id": "68999-803_46a3a089-45f8-184c-e063-6294a90a9bc4", "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": "68999-803", "generic_name": "Acyclovir", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acyclovir", "active_ingredients": [{"name": "ACYCLOVIR", "strength": "200 mg/5mL"}], "application_number": "ANDA212718", "marketing_category": "ANDA", "marketing_start_date": "20200423", "listing_expiration_date": "20261231"}