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United States · US · US:63187-076_1e43585a-8e75-4a75-a011-56b5f80cb7cd

Benzonatate

Orange BookUNIISPLATC R05DB01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR05DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6318707614
    14 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-14)
  • ndc11
    6318707620
    20 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-20)
  • ndc11
    6318707630
    30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-30)
  • ndc11
    6318707640
    40 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-40)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A040682
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": "63187-076_1e43585a-8e75-4a75-a011-56b5f80cb7cd",
  "productndc": "63187-076",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "040682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 30, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jul 30, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "Benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20100604",
  "active_numerator_strength": "100"
}

Related drugs

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