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United States · US · US:68788-8329_8107f64d-3336-46e7-b06c-e10c39d8beb5

Benzonatate

Orange BookUNIISPLATC R05DB01

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

Identification

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

Packs · 4

  • ndc11
    6878883291
    15 CAPSULE in 1 BOTTLE (68788-8329-1)
  • ndc11
    6878883292
    20 CAPSULE in 1 BOTTLE (68788-8329-2)
  • ndc11
    6878883293
    30 CAPSULE in 1 BOTTLE (68788-8329-3)
  • ndc11
    6878883296
    60 CAPSULE in 1 BOTTLE (68788-8329-6)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A206948
AAAA
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": "68788-8329_8107f64d-3336-46e7-b06c-e10c39d8beb5",
  "productndc": "68788-8329",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206948",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 19, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "Benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206948",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20230120",
  "active_numerator_strength": "200"
}

Related drugs

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