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United States · US · US:63187-606_ab1812ff-a83c-466e-944b-c81630d1c8fd
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 · 6
- ndc11631876061414 CAPSULE in 1 BOTTLE (63187-606-14)
- ndc11631876062020 CAPSULE in 1 BOTTLE (63187-606-20)
- ndc11631876062121 CAPSULE in 1 BOTTLE (63187-606-21)
- ndc11631876063030 CAPSULE in 1 BOTTLE (63187-606-30)
- ndc11631876064040 CAPSULE in 1 BOTTLE (63187-606-40)
- ndc11631876066060 CAPSULE in 1 BOTTLE (63187-606-60)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A202765
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": "63187-606_ab1812ff-a83c-466e-944b-c81630d1c8fd",
"productndc": "63187-606",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202765",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jul 31, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "002",
"approval_date": "Aug 25, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZONATATE",
"proprietary_name": "Benzonatate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202765",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate",
"start_marketing_date": "20150810",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code R05DB01.
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