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United States · US · US:71205-643_6bfa0eeb-17e2-4b47-a91b-546d67af50d5
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
- ndc11712056431010 CAPSULE in 1 BOTTLE (71205-643-10)
- ndc11712056431414 CAPSULE in 1 BOTTLE (71205-643-14)
- ndc11712056431515 CAPSULE in 1 BOTTLE (71205-643-15)
- ndc11712056432020 CAPSULE in 1 BOTTLE (71205-643-20)
- ndc11712056432121 CAPSULE in 1 BOTTLE (71205-643-21)
- ndc11712056433030 CAPSULE in 1 BOTTLE (71205-643-30)
- ndc11712056436060 CAPSULE in 1 BOTTLE (71205-643-60)
- ndc11712056439090 CAPSULE in 1 BOTTLE (71205-643-90)
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": "71205-643_6bfa0eeb-17e2-4b47-a91b-546d67af50d5",
"productndc": "71205-643",
"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": "200"
}Related drugs
Other records sharing ATC code R05DB01.
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