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United States · US · US:82804-265_28b31f37-6896-40f5-8f3a-60c93c5c1278
GUAIFENESIN
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11828042652020 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-265-20)
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "495W7451VQ",
"rxcui": "5032",
"inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
"display_name": "GUAIFENESIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
"match": "brand_token",
"title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
"spl_version": "8",
"published_date": "2026-05-21"
}
},
"productid": "82804-265_28b31f37-6896-40f5-8f3a-60c93c5c1278",
"productndc": "82804-265",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213420",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "May 8, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "May 8, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "GUAIFENESIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213420",
"marketing_category": "ANDA",
"nonproprietary_name": "GUAIFENESIN",
"start_marketing_date": "20220819",
"active_numerator_strength": "600"
}Related drugs
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