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United States · US · US:71335-1329_2e12fdc7-0714-440e-b918-4a080745f10d
benzonatate
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc11713351329010 CAPSULE in 1 BOTTLE (71335-1329-0)
- ndc11713351329130 CAPSULE in 1 BOTTLE (71335-1329-1)
- ndc11713351329220 CAPSULE in 1 BOTTLE (71335-1329-2)
- ndc117133513293100 CAPSULE in 1 BOTTLE (71335-1329-3)
- ndc11713351329415 CAPSULE in 1 BOTTLE (71335-1329-4)
- ndc117133513295120 CAPSULE in 1 BOTTLE (71335-1329-5)
- ndc11713351329660 CAPSULE in 1 BOTTLE (71335-1329-6)
- ndc11713351329790 CAPSULE in 1 BOTTLE (71335-1329-7)
- ndc11713351329814 CAPSULE in 1 BOTTLE (71335-1329-8)
- ndc11713351329940 CAPSULE in 1 BOTTLE (71335-1329-9)
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": "71335-1329_2e12fdc7-0714-440e-b918-4a080745f10d",
"productndc": "71335-1329",
"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": "20170322",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R05DB01.
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