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United States · US · US:71205-632_a449d609-2233-477e-bdb7-df2c84a1b495

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 · 7

  • ndc11
    7120563210
    10 CAPSULE in 1 BOTTLE (71205-632-10)
  • ndc11
    7120563215
    15 CAPSULE in 1 BOTTLE (71205-632-15)
  • ndc11
    7120563220
    20 CAPSULE in 1 BOTTLE (71205-632-20)
  • ndc11
    7120563221
    21 CAPSULE in 1 BOTTLE (71205-632-21)
  • ndc11
    7120563230
    30 CAPSULE in 1 BOTTLE (71205-632-30)
  • ndc11
    7120563260
    60 CAPSULE in 1 BOTTLE (71205-632-60)
  • ndc11
    7120563290
    90 CAPSULE in 1 BOTTLE (71205-632-90)

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": "71205-632_a449d609-2233-477e-bdb7-df2c84a1b495",
  "productndc": "71205-632",
  "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

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