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United States · US · US:71610-692_48b92534-e189-4b18-906f-8a4abcb776a4
Benzonatate
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11716106923030 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-30)
- ndc11716106925360 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-53)
- ndc11716106926090 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-60)
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": "71610-692_48b92534-e189-4b18-906f-8a4abcb776a4",
"productndc": "71610-692",
"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": "20170118",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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