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United States · US · US:0093-3630_41d48b5c-d1d0-66d0-e063-6294a90ab384

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093363020
    1 TUBE in 1 CARTON (0093-3630-20) / 5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
N021478
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": "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": "0093-3630_41d48b5c-d1d0-66d0-e063-6294a90ab384",
  "productndc": "0093-3630",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "021478",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Dec 30, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA021478",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "acyclovir",
  "start_marketing_date": "20190829",
  "active_numerator_strength": "50"
}

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