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United States · US · US:71335-1544_6a75cf59-91fe-4201-8c04-4b24dcad76e0

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 · 10

  • ndc11
    7133515440
    10 CAPSULE in 1 BOTTLE (71335-1544-0)
  • ndc11
    7133515441
    30 CAPSULE in 1 BOTTLE (71335-1544-1)
  • ndc11
    7133515442
    20 CAPSULE in 1 BOTTLE (71335-1544-2)
  • ndc11
    7133515443
    100 CAPSULE in 1 BOTTLE (71335-1544-3)
  • ndc11
    7133515444
    15 CAPSULE in 1 BOTTLE (71335-1544-4)
  • ndc11
    7133515445
    120 CAPSULE in 1 BOTTLE (71335-1544-5)
  • ndc11
    7133515446
    60 CAPSULE in 1 BOTTLE (71335-1544-6)
  • ndc11
    7133515447
    90 CAPSULE in 1 BOTTLE (71335-1544-7)
  • ndc11
    7133515448
    14 CAPSULE in 1 BOTTLE (71335-1544-8)
  • ndc11
    7133515449
    40 CAPSULE in 1 BOTTLE (71335-1544-9)

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": "71335-1544_6a75cf59-91fe-4201-8c04-4b24dcad76e0",
  "productndc": "71335-1544",
  "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": "100"
}

Related drugs

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