Benzonatate

Orange BookUNIISPLATC R05DB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeR05DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7278923006
6 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-06)
ndc11
7278923012
12 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-12)
ndc11
7278923015
15 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-15)
ndc11
7278923020
20 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-20)
ndc11
7278923021
21 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-21)
ndc11
7278923030
30 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-30)

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": "72789-230_2d6c8457-a91d-08a1-e063-6294a90a2807",
  "productndc": "72789-230",
  "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": "100"
}

Related drugs

Other records sharing ATC code R05DB01.

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