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United States · US · US:71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27

Terbinafine Hydrochloride

Orange BookUNIISPLATC D01AE15

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AE15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133509181
    30 TABLET in 1 BOTTLE (71335-0918-1)
  • ndc11
    7133509182
    60 TABLET in 1 BOTTLE (71335-0918-2)
  • ndc11
    7133509183
    90 TABLET in 1 BOTTLE (71335-0918-3)
  • ndc11
    7133509184
    100 TABLET in 1 BOTTLE (71335-0918-4)
  • ndc11
    7133509185
    7 TABLET in 1 BOTTLE (71335-0918-5)
  • ndc11
    7133509186
    40 TABLET in 1 BOTTLE (71335-0918-6)
  • ndc11
    7133509187
    45 TABLET in 1 BOTTLE (71335-0918-7)
  • ndc11
    7133509188
    14 TABLET in 1 BOTTLE (71335-0918-8)
  • ndc11
    7133509189
    28 TABLET in 1 BOTTLE (71335-0918-9)

Annotations

UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A077714
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "012C11ZU6G",
    "rxcui": "235838",
    "inchikey": "BWMISRWJRUSYEX-SZKNIZGXSA-N",
    "display_name": "TERBINAFINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "50750500-6cb0-62dc-e063-6294a90a15bc": {
      "match": "brand_token",
      "title": "TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-29"
    }
  },
  "productid": "71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27",
  "productndc": "71335-0918",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077714",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Jun 4, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERBINAFINE HYDROCHLORIDE",
  "proprietary_name": "Terbinafine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077714",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terbinafine Hydrochloride",
  "start_marketing_date": "20101227",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code D01AE15.

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