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United States · US · US:70771-1808_400d6da5-8a57-4156-a3ef-4aaacfe2d7ef

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 · 2

  • ndc11
    7077118082
    1 TUBE in 1 CARTON (70771-1808-2) / 2 g in 1 TUBE
  • ndc11
    7077118085
    1 TUBE in 1 CARTON (70771-1808-5) / 5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A206770
BX
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": "TOPICAL",
  "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": "70771-1808_400d6da5-8a57-4156-a3ef-4aaacfe2d7ef",
  "productndc": "70771-1808",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "206770",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Feb 28, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA206770",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acyclovir",
  "start_marketing_date": "20230303",
  "active_numerator_strength": "50"
}

Related drugs

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