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United States · US · US:71205-673_8dcaeabf-e7da-4e0c-b6db-0bd425d6506e

Benzonatate

Orange BookUNIISPLATC R05DB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR05DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7120567306
    6 CAPSULE in 1 BOTTLE (71205-673-06)
  • ndc11
    7120567310
    10 CAPSULE in 1 BOTTLE (71205-673-10)
  • ndc11
    7120567314
    14 CAPSULE in 1 BOTTLE (71205-673-14)
  • ndc11
    7120567315
    15 CAPSULE in 1 BOTTLE (71205-673-15)
  • ndc11
    7120567320
    20 CAPSULE in 1 BOTTLE (71205-673-20)
  • ndc11
    7120567321
    21 CAPSULE in 1 BOTTLE (71205-673-21)
  • ndc11
    7120567330
    30 CAPSULE in 1 BOTTLE (71205-673-30)
  • ndc11
    7120567360
    60 CAPSULE in 1 BOTTLE (71205-673-60)
  • ndc11
    7120567390
    90 CAPSULE in 1 BOTTLE (71205-673-90)

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": "71205-673_8dcaeabf-e7da-4e0c-b6db-0bd425d6506e",
  "productndc": "71205-673",
  "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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