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United States · US · US:63629-9189_80562a9e-3b6f-4a6e-b09c-dda37736523c
Benzonatate
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116362991891500 CAPSULE in 1 BOTTLE (63629-9189-1)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A202765
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": "63629-9189_80562a9e-3b6f-4a6e-b09c-dda37736523c",
"productndc": "63629-9189",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202765",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jul 31, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "002",
"approval_date": "Aug 25, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZONATATE",
"proprietary_name": "Benzonatate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202765",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate",
"start_marketing_date": "20170907",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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