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United States · US · US:0615-8403_888d70d8-eda7-4bca-b78c-30fc56231aba
Benzonatate
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11061584030515 CAPSULE in 1 BLISTER PACK (0615-8403-05)
- ndc11061584032121 CAPSULE in 1 BLISTER PACK (0615-8403-21)
- ndc11061584033930 CAPSULE in 1 BLISTER PACK (0615-8403-39)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A091133
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": "0615-8403_888d70d8-eda7-4bca-b78c-30fc56231aba",
"productndc": "0615-8403",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "091133",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 30, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "002",
"approval_date": "Jul 30, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZONATATE",
"proprietary_name": "Benzonatate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091133",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate",
"start_marketing_date": "20161210",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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