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United States · US · US:71335-2790_bfae9fd9-1847-4503-9c29-85187a0fc39a

Benzonatate

Orange BookUNIISPLATC R05DB01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR05DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7133527901
    21 CAPSULE in 1 BOTTLE (71335-2790-1)
  • ndc11
    7133527902
    100 CAPSULE in 1 BOTTLE (71335-2790-2)
  • ndc11
    7133527903
    500 CAPSULE in 1 BOTTLE (71335-2790-3)
  • ndc11
    7133527904
    10 CAPSULE in 1 BOTTLE (71335-2790-4)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A040597
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": "71335-2790_bfae9fd9-1847-4503-9c29-85187a0fc39a",
  "productndc": "71335-2790",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "040597",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 8, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jun 8, 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": "ANDA040597",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20070409",
  "active_numerator_strength": "200"
}

Related drugs

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