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United States · US · US:71205-699_47560d98-f4c4-4738-85fe-41cbed09ed59
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 · 8
- ndc11712056991010 CAPSULE in 1 BOTTLE (71205-699-10)
- ndc11712056991414 CAPSULE in 1 BOTTLE (71205-699-14)
- ndc11712056992020 CAPSULE in 1 BOTTLE (71205-699-20)
- ndc11712056992121 CAPSULE in 1 BOTTLE (71205-699-21)
- ndc11712056992424 CAPSULE in 1 BOTTLE (71205-699-24)
- ndc11712056993030 CAPSULE in 1 BOTTLE (71205-699-30)
- ndc11712056996060 CAPSULE in 1 BOTTLE (71205-699-60)
- ndc11712056999090 CAPSULE in 1 BOTTLE (71205-699-90)
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": "71205-699_47560d98-f4c4-4738-85fe-41cbed09ed59",
"productndc": "71205-699",
"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": "20190222",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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