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United States · US · US:72865-117_f3f6fdbf-2aa1-4ce3-b3aa-abab79b546c1
Benzonatate
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXLCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117286511701100 CAPSULE in 1 BOTTLE (72865-117-01)
- ndc117286511705500 CAPSULE in 1 BOTTLE (72865-117-05)
- ndc11728651173030 CAPSULE in 1 BOTTLE (72865-117-30)
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": "72865-117_f3f6fdbf-2aa1-4ce3-b3aa-abab79b546c1",
"productndc": "72865-117",
"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": "20200217",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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