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United States · US · US:65841-829_60403e35-9772-472d-ba86-f4f373060ee9

acyclovir

Orange BookUNIISPLATC J05AB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6584182901
    100 CAPSULE in 1 BOTTLE (65841-829-01)
  • ndc11
    6584182905
    500 CAPSULE in 1 BOTTLE (65841-829-05)
  • ndc11
    6584182906
    30 CAPSULE in 1 BOTTLE (65841-829-06)
  • ndc11
    6584182910
    1000 CAPSULE in 1 BOTTLE (65841-829-10)
  • ndc11
    6584182916
    90 CAPSULE in 1 BOTTLE (65841-829-16)

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A204313
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "X4HES1O11F",
    "rxcui": "281",
    "inchikey": "MKUXAQIIEYXACX-UHFFFAOYSA-N",
    "display_name": "ACYCLOVIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0": {
      "match": "brand_token",
      "title": "ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "19",
      "published_date": "2026-05-28"
    }
  },
  "productid": "65841-829_60403e35-9772-472d-ba86-f4f373060ee9",
  "productndc": "65841-829",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204313",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Mar 25, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "acyclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204313",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acyclovir",
  "start_marketing_date": "20160503",
  "active_numerator_strength": "200"
}

Related drugs

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