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United States · US · US:71335-0091_f721a18a-c457-4c4a-98de-2288d21916a7

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
    7133500910
    10 CAPSULE in 1 BOTTLE (71335-0091-0)
  • ndc11
    7133500911
    30 CAPSULE in 1 BOTTLE (71335-0091-1)
  • ndc11
    7133500912
    20 CAPSULE in 1 BOTTLE (71335-0091-2)
  • ndc11
    7133500913
    100 CAPSULE in 1 BOTTLE (71335-0091-3)
  • ndc11
    7133500914
    15 CAPSULE in 1 BOTTLE (71335-0091-4)
  • ndc11
    7133500915
    120 CAPSULE in 1 BOTTLE (71335-0091-5)
  • ndc11
    7133500916
    60 CAPSULE in 1 BOTTLE (71335-0091-6)
  • ndc11
    7133500917
    90 CAPSULE in 1 BOTTLE (71335-0091-7)
  • ndc11
    7133500918
    14 CAPSULE in 1 BOTTLE (71335-0091-8)
  • ndc11
    7133500919
    40 CAPSULE in 1 BOTTLE (71335-0091-9)

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": "71335-0091_f721a18a-c457-4c4a-98de-2288d21916a7",
  "productndc": "71335-0091",
  "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": "100"
}

Related drugs

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