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United States · US · US:71921-146_3df7fa38-a869-45fb-98a3-81c5a2527d62

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7192114601
    100 CAPSULE in 1 BOTTLE (71921-146-01)

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A075090
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": "71921-146_3df7fa38-a869-45fb-98a3-81c5a2527d62",
  "productndc": "71921-146",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075090",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jan 26, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075090",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acyclovir",
  "start_marketing_date": "20260218",
  "active_numerator_strength": "200"
}

Related drugs

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