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United States · US · US:25000-003_8668f10d-45dc-4248-88ac-6e8c5d576435
Benzonatate 200 mg
Orange BookUNIISPLATC R05DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeR05DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11250000030330 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-003-03)
- ndc112500000308100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-003-08)
- ndc112500000312500 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-003-12)
Annotations
UNII (FDA Substance ID)
5P4DHS6ENR
BENZONATATE
RxCUI 18993
Orange Book
A220298
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": "25000-003_8668f10d-45dc-4248-88ac-6e8c5d576435",
"productndc": "25000-003",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "220298",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 30, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "200MG",
"product_no": "002",
"approval_date": "Mar 30, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZONATATE",
"proprietary_name": "Benzonatate 200 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA220298",
"marketing_category": "ANDA",
"nonproprietary_name": "Benzonatate 200 mg",
"start_marketing_date": "20260410",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code R05DB01.
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