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United States · US · US:71335-1927_45902888-6422-4ada-8cc1-a44d76468ae5

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
    7133519270
    10 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-0)
  • ndc11
    7133519271
    30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-1)
  • ndc11
    7133519272
    20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-2)
  • ndc11
    7133519273
    100 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-3)
  • ndc11
    7133519274
    15 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-4)
  • ndc11
    7133519275
    120 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-5)
  • ndc11
    7133519276
    60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-6)
  • ndc11
    7133519277
    90 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-7)
  • ndc11
    7133519278
    14 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-8)
  • ndc11
    7133519279
    40 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-9)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A081297
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": "71335-1927_45902888-6422-4ada-8cc1-a44d76468ae5",
  "productndc": "71335-1927",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "081297",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 29, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Oct 30, 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": "ANDA081297",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20160815",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code R05DB01.

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