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United States · US · US:63187-799_f4c90607-02fd-4956-809c-6045cb48720c
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 · 5
- ndc11631877991414 CAPSULE in 1 BOTTLE (63187-799-14)
- ndc11631877991515 CAPSULE in 1 BOTTLE (63187-799-15)
- ndc11631877992020 CAPSULE in 1 BOTTLE (63187-799-20)
- ndc11631877993030 CAPSULE in 1 BOTTLE (63187-799-30)
- ndc11631877994040 CAPSULE in 1 BOTTLE (63187-799-40)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A040597
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": "63187-799_f4c90607-02fd-4956-809c-6045cb48720c",
"productndc": "63187-799",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "040597",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 8, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "002",
"approval_date": "Jun 8, 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": "ANDA040597",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate",
"start_marketing_date": "20070409",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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