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United States · US · US:70518-2491_51dff223-f709-c42d-e063-6294a90abcc3
Benzonatate
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11705182491330 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-3)
- ndc11705182491421 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-4)
- ndc11705182491520 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-5)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A206948
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": "70518-2491_51dff223-f709-c42d-e063-6294a90abcc3",
"productndc": "70518-2491",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "206948",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Dec 19, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "002",
"approval_date": "Dec 19, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZONATATE",
"proprietary_name": "Benzonatate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206948",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate",
"start_marketing_date": "20191217",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code R05DB01.
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