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United States · US · US:71335-0688_1c471368-6338-4e1e-b93d-8fcb5022a1f5

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
    7133506880
    10 CAPSULE in 1 BOTTLE (71335-0688-0)
  • ndc11
    7133506881
    30 CAPSULE in 1 BOTTLE (71335-0688-1)
  • ndc11
    7133506882
    20 CAPSULE in 1 BOTTLE (71335-0688-2)
  • ndc11
    7133506883
    100 CAPSULE in 1 BOTTLE (71335-0688-3)
  • ndc11
    7133506884
    15 CAPSULE in 1 BOTTLE (71335-0688-4)
  • ndc11
    7133506885
    120 CAPSULE in 1 BOTTLE (71335-0688-5)
  • ndc11
    7133506886
    60 CAPSULE in 1 BOTTLE (71335-0688-6)
  • ndc11
    7133506887
    90 CAPSULE in 1 BOTTLE (71335-0688-7)
  • ndc11
    7133506888
    14 CAPSULE in 1 BOTTLE (71335-0688-8)
  • ndc11
    7133506889
    40 CAPSULE in 1 BOTTLE (71335-0688-9)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A040627
AAAAAA
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": "71335-0688_1c471368-6338-4e1e-b93d-8fcb5022a1f5",
  "productndc": "71335-0688",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "040627",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Sep 24, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040627",
  "marketing_category": "ANDA",
  "nonproprietary_name": "benzonatate",
  "start_marketing_date": "20170322",
  "active_numerator_strength": "100"
}

Related drugs

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