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 · 7

ndc11
6318792810
10 CAPSULE in 1 BOTTLE (63187-928-10)
ndc11
6318792814
14 CAPSULE in 1 BOTTLE (63187-928-14)
ndc11
6318792815
15 CAPSULE in 1 BOTTLE (63187-928-15)
ndc11
6318792820
20 CAPSULE in 1 BOTTLE (63187-928-20)
ndc11
6318792821
21 CAPSULE in 1 BOTTLE (63187-928-21)
ndc11
6318792830
30 CAPSULE in 1 BOTTLE (63187-928-30)
ndc11
6318792840
40 CAPSULE in 1 BOTTLE (63187-928-40)

Annotations

UNII (FDA Substance ID)

5P4DHS6ENR

BENZONATATE

RxCUI 18993

Orange Book

A040627

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": "63187-928_5b03582e-fcc5-4cbb-8a72-0c53fcc32900",
  "productndc": "63187-928",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "040627",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Sep 24, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZONATATE",
  "proprietary_name": "benzonatate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040627",
  "marketing_category": "ANDA",
  "nonproprietary_name": "benzonatate",
  "start_marketing_date": "20170322",
  "active_numerator_strength": "100"
}

Related drugs

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