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United States · US · US:68788-7607_33ce4923-a290-4c25-95f2-67f8b25fd3e9

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 · 7

  • ndc11
    6878876070
    9 CAPSULE in 1 BOTTLE (68788-7607-0)
  • ndc11
    6878876071
    100 CAPSULE in 1 BOTTLE (68788-7607-1)
  • ndc11
    6878876072
    20 CAPSULE in 1 BOTTLE (68788-7607-2)
  • ndc11
    6878876073
    30 CAPSULE in 1 BOTTLE (68788-7607-3)
  • ndc11
    6878876074
    40 CAPSULE in 1 BOTTLE (68788-7607-4)
  • ndc11
    6878876075
    15 CAPSULE in 1 BOTTLE (68788-7607-5)
  • ndc11
    6878876079
    90 CAPSULE in 1 BOTTLE (68788-7607-9)

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": "68788-7607_33ce4923-a290-4c25-95f2-67f8b25fd3e9",
  "productndc": "68788-7607",
  "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": "20200207",
  "active_numerator_strength": "100"
}

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