Benzonatate

Orange BookUNIISPLATC R05DB01

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeR05DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8576606701
100 CAPSULE in 1 BOTTLE (85766-067-01)
ndc11
8576606705
500 CAPSULE in 1 BOTTLE (85766-067-05)
ndc11
8576606715
15 CAPSULE in 1 BOTTLE (85766-067-15)
ndc11
8576606720
20 CAPSULE in 1 BOTTLE (85766-067-20)
ndc11
8576606721
21 CAPSULE in 1 BOTTLE (85766-067-21)
ndc11
8576606730
30 CAPSULE in 1 BOTTLE (85766-067-30)
ndc11
8576606760
60 CAPSULE in 1 BOTTLE (85766-067-60)
ndc11
8576606790
90 CAPSULE in 1 BOTTLE (85766-067-90)

Annotations

UNII (FDA Substance ID)

5P4DHS6ENR

BENZONATATE

RxCUI 18993

Orange Book

A211518

AAAAAA

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": "85766-067_502f32fd-33c9-391e-e063-6394a90a30b6",
  "productndc": "85766-067",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211518",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Feb 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Feb 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "Benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211518",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzonatate",
  "start_marketing_date": "20190222",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code R05DB01.

Access this data programmatically

Query Benzonatate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs