Benzonatate

Orange BookUNIISPLATC R05DB01

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

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
7120506710
10 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-10)
ndc11
7120506714
14 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-14)
ndc11
7120506715
15 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-15)
ndc11
7120506720
20 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-20)
ndc11
7120506721
21 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-21)
ndc11
7120506730
30 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-30)
ndc11
7120506740
40 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-40)
ndc11
7120506760
60 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-60)
ndc11
7120506790
90 CAPSULE in 1 BOTTLE, PLASTIC (71205-067-90)

Annotations

UNII (FDA Substance ID)

5P4DHS6ENR

BENZONATATE

RxCUI 18993

Orange Book

A081297

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": "71205-067_1d853cad-1e12-4851-83a6-5e346a8285e1",
  "productndc": "71205-067",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "081297",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 29, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "Benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA081297",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20160815",
  "active_numerator_strength": "100"
}

Related drugs

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