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United States · US · US:63187-076_1e43585a-8e75-4a75-a011-56b5f80cb7cd
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 · 4
- ndc11631870761414 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-14)
- ndc11631870762020 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-20)
- ndc11631870763030 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-30)
- ndc11631870764040 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-40)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A040682
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": "63187-076_1e43585a-8e75-4a75-a011-56b5f80cb7cd",
"productndc": "63187-076",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "040682",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 30, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "002",
"approval_date": "Jul 30, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZONATATE",
"proprietary_name": "Benzonatate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040682",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate",
"start_marketing_date": "20100604",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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