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United States · US · US:71205-632_a449d609-2233-477e-bdb7-df2c84a1b495
Benzonatate
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11712056321010 CAPSULE in 1 BOTTLE (71205-632-10)
- ndc11712056321515 CAPSULE in 1 BOTTLE (71205-632-15)
- ndc11712056322020 CAPSULE in 1 BOTTLE (71205-632-20)
- ndc11712056322121 CAPSULE in 1 BOTTLE (71205-632-21)
- ndc11712056323030 CAPSULE in 1 BOTTLE (71205-632-30)
- ndc11712056326060 CAPSULE in 1 BOTTLE (71205-632-60)
- ndc11712056329090 CAPSULE in 1 BOTTLE (71205-632-90)
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": "71205-632_a449d609-2233-477e-bdb7-df2c84a1b495",
"productndc": "71205-632",
"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": "20181221",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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