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United States · US · US:85766-090_4ed84766-51d2-3f2e-e063-6294a90a4109

Benzonatate

Orange BookUNIISPLATC R05DB01

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    8576609001
    100 CAPSULE in 1 BOTTLE (85766-090-01)
  • ndc11
    8576609005
    500 CAPSULE in 1 BOTTLE (85766-090-05)
  • ndc11
    8576609010
    10 CAPSULE in 1 BOTTLE (85766-090-10)
  • ndc11
    8576609020
    20 CAPSULE in 1 BOTTLE (85766-090-20)
  • ndc11
    8576609021
    21 CAPSULE in 1 BOTTLE (85766-090-21)
  • ndc11
    8576609030
    30 CAPSULE in 1 BOTTLE (85766-090-30)
  • ndc11
    8576609060
    60 CAPSULE in 1 BOTTLE (85766-090-60)
  • ndc11
    8576609090
    90 CAPSULE in 1 BOTTLE (85766-090-90)

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": "85766-090_4ed84766-51d2-3f2e-e063-6294a90a4109",
  "productndc": "85766-090",
  "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": "20181221",
  "active_numerator_strength": "200"
}

Related drugs

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