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United States · US · US:67046-1629_463d6418-04ce-05f0-e063-6294a90ac910
BENZONATATE
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461629330 CAPSULE in 1 BLISTER PACK (67046-1629-3)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A040627
AAAAAA
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": "67046-1629_463d6418-04ce-05f0-e063-6294a90ac910",
"productndc": "67046-1629",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "040627",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 30, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "002",
"approval_date": "Jul 25, 2007"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "150MG",
"product_no": "003",
"approval_date": "Sep 24, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZONATATE",
"proprietary_name": "BENZONATATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040627",
"marketing_category": "ANDA",
"nonproprietary_name": "BENZONATATE",
"start_marketing_date": "20251218",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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