Benzonatate

Orange BookUNIISPLATC R05DB01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeR05DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133518800
6 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-0)
ndc11
7133518801
30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-1)
ndc11
7133518802
100 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-2)
ndc11
7133518803
45 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-3)
ndc11
7133518804
20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-4)
ndc11
7133518805
15 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-5)
ndc11
7133518806
21 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-6)
ndc11
7133518807
60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-7)
ndc11
7133518808
50 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-8)
ndc11
7133518809
90 CAPSULE in 1 BOTTLE, PLASTIC (71335-1880-9)

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": "71335-1880_f32253b6-50e9-42a0-a1d1-f93a8c0f048d",
  "productndc": "71335-1880",
  "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": "200"
}

Related drugs

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