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United States · US · US:70518-3436_5071b891-7d0a-23d6-e063-6294a90a4b33

acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7051834360
    30 CAPSULE in 1 BLISTER PACK (70518-3436-0)
  • ndc11
    7051834361
    50 POUCH in 1 BOX (70518-3436-1) / 1 CAPSULE in 1 POUCH (70518-3436-2)

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": "70518-3436_5071b891-7d0a-23d6-e063-6294a90a4b33",
  "productndc": "70518-3436",
  "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": "20220614",
  "active_numerator_strength": "200"
}

Related drugs

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