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United States · US · US:71335-2021_e1c77f1a-79d0-4c5d-a011-fd5c8cd59ffe

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 · 9

  • ndc11
    7133520211
    30 CAPSULE in 1 BOTTLE (71335-2021-1)
  • ndc11
    7133520212
    100 CAPSULE in 1 BOTTLE (71335-2021-2)
  • ndc11
    7133520213
    45 CAPSULE in 1 BOTTLE (71335-2021-3)
  • ndc11
    7133520214
    20 CAPSULE in 1 BOTTLE (71335-2021-4)
  • ndc11
    7133520215
    15 CAPSULE in 1 BOTTLE (71335-2021-5)
  • ndc11
    7133520216
    21 CAPSULE in 1 BOTTLE (71335-2021-6)
  • ndc11
    7133520217
    60 CAPSULE in 1 BOTTLE (71335-2021-7)
  • ndc11
    7133520218
    50 CAPSULE in 1 BOTTLE (71335-2021-8)
  • ndc11
    7133520219
    90 CAPSULE in 1 BOTTLE (71335-2021-9)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A040682
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": "71335-2021_e1c77f1a-79d0-4c5d-a011-fd5c8cd59ffe",
  "productndc": "71335-2021",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "040682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 30, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jul 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": "ANDA040682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BENZONATATE",
  "start_marketing_date": "20180501",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code R05DB01.

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