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United States · US · US:71205-643_6bfa0eeb-17e2-4b47-a91b-546d67af50d5

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 · 8

  • ndc11
    7120564310
    10 CAPSULE in 1 BOTTLE (71205-643-10)
  • ndc11
    7120564314
    14 CAPSULE in 1 BOTTLE (71205-643-14)
  • ndc11
    7120564315
    15 CAPSULE in 1 BOTTLE (71205-643-15)
  • ndc11
    7120564320
    20 CAPSULE in 1 BOTTLE (71205-643-20)
  • ndc11
    7120564321
    21 CAPSULE in 1 BOTTLE (71205-643-21)
  • ndc11
    7120564330
    30 CAPSULE in 1 BOTTLE (71205-643-30)
  • ndc11
    7120564360
    60 CAPSULE in 1 BOTTLE (71205-643-60)
  • ndc11
    7120564390
    90 CAPSULE in 1 BOTTLE (71205-643-90)

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": "71205-643_6bfa0eeb-17e2-4b47-a91b-546d67af50d5",
  "productndc": "71205-643",
  "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"
}

Related drugs

Other records sharing ATC code R05DB01.

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