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United States · US · US:71205-605_2fae3438-3fe9-4f4f-bd89-35fb7050c560
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 · 9
- ndc11712056051010 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-10)
- ndc11712056051414 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-14)
- ndc11712056051515 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-15)
- ndc11712056052020 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-20)
- ndc11712056052121 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-21)
- ndc11712056053030 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-30)
- ndc11712056054040 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-40)
- ndc11712056056060 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-60)
- ndc11712056059090 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-90)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A081297
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": "71205-605_2fae3438-3fe9-4f4f-bd89-35fb7050c560",
"productndc": "71205-605",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "081297",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jan 29, 1993"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "002",
"approval_date": "Oct 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": "ANDA081297",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate",
"start_marketing_date": "20160815",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code R05DB01.
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