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United States · US · US:72865-117_f3f6fdbf-2aa1-4ce3-b3aa-abab79b546c1

Benzonatate

Orange BookUNIISPLATC R05DB01

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

Identification

ManufacturerXLCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR05DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7286511701
    100 CAPSULE in 1 BOTTLE (72865-117-01)
  • ndc11
    7286511705
    500 CAPSULE in 1 BOTTLE (72865-117-05)
  • ndc11
    7286511730
    30 CAPSULE in 1 BOTTLE (72865-117-30)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A211518
AAAAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5P4DHS6ENR",
    "rxcui": "18993",
    "inchikey": null,
    "display_name": "BENZONATATE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52c5cb10-0877-e27f-e063-6394a90a4a2d": {
      "match": "brand_token",
      "title": "BENZONATATE CAPSULE [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "72865-117_f3f6fdbf-2aa1-4ce3-b3aa-abab79b546c1",
  "productndc": "72865-117",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211518",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Feb 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Feb 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "Benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211518",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20200217",
  "active_numerator_strength": "100"
}

Related drugs

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