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United States · US · US:51672-1360_3ff34f4c-91c2-acec-e063-6394a90a722b

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5167213601
    1 TUBE in 1 CARTON (51672-1360-1) / 15 g in 1 TUBE
  • ndc11
    5167213602
    1 TUBE in 1 CARTON (51672-1360-2) / 30 g in 1 TUBE
  • ndc11
    5167213605
    1 TUBE in 1 CARTON (51672-1360-5) / 5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A205469
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": "51672-1360_3ff34f4c-91c2-acec-e063-6394a90a722b",
  "productndc": "51672-1360",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "205469",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Dec 21, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA205469",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acyclovir",
  "start_marketing_date": "20161221",
  "active_numerator_strength": "50"
}

Related drugs

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