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United States · US · US:71335-1553_6a75cf59-91fe-4201-8c04-4b24dcad76e0

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
    7133515531
    30 CAPSULE in 1 BOTTLE (71335-1553-1)
  • ndc11
    7133515532
    100 CAPSULE in 1 BOTTLE (71335-1553-2)
  • ndc11
    7133515533
    45 CAPSULE in 1 BOTTLE (71335-1553-3)
  • ndc11
    7133515534
    20 CAPSULE in 1 BOTTLE (71335-1553-4)
  • ndc11
    7133515535
    15 CAPSULE in 1 BOTTLE (71335-1553-5)
  • ndc11
    7133515536
    21 CAPSULE in 1 BOTTLE (71335-1553-6)
  • ndc11
    7133515537
    60 CAPSULE in 1 BOTTLE (71335-1553-7)
  • ndc11
    7133515538
    50 CAPSULE in 1 BOTTLE (71335-1553-8)
  • ndc11
    7133515539
    90 CAPSULE in 1 BOTTLE (71335-1553-9)

Annotations

UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A206948
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": "71335-1553_6a75cf59-91fe-4201-8c04-4b24dcad76e0",
  "productndc": "71335-1553",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206948",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 19, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "Benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206948",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20181221",
  "active_numerator_strength": "200"
}

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