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United States · US · US:71335-2486_2e05a0b4-61a5-42c5-83ae-e6a2b60c6330

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
    7133524860
    6 CAPSULE in 1 BOTTLE (71335-2486-0)
  • ndc11
    7133524861
    30 CAPSULE in 1 BOTTLE (71335-2486-1)
  • ndc11
    7133524862
    100 CAPSULE in 1 BOTTLE (71335-2486-2)
  • ndc11
    7133524863
    45 CAPSULE in 1 BOTTLE (71335-2486-3)
  • ndc11
    7133524864
    20 CAPSULE in 1 BOTTLE (71335-2486-4)
  • ndc11
    7133524865
    15 CAPSULE in 1 BOTTLE (71335-2486-5)
  • ndc11
    7133524866
    21 CAPSULE in 1 BOTTLE (71335-2486-6)
  • ndc11
    7133524867
    60 CAPSULE in 1 BOTTLE (71335-2486-7)
  • ndc11
    7133524868
    50 CAPSULE in 1 BOTTLE (71335-2486-8)
  • ndc11
    7133524869
    90 CAPSULE in 1 BOTTLE (71335-2486-9)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A211518
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": "71335-2486_2e05a0b4-61a5-42c5-83ae-e6a2b60c6330",
  "productndc": "71335-2486",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211518",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Feb 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Feb 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "Benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211518",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20190222",
  "active_numerator_strength": "200"
}

Related drugs

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