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United States · US · US:46122-801_775000bc-56de-4c72-87da-65bb33f063b3
Guaifenesin and Pseudoephedrine HCl
Orange BookUNIISPLATC R05CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerisource Bergen
CountryUS (United States)
ATC codeR05CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1146122801081 BLISTER PACK in 1 CARTON (46122-801-08) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213203
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": "46122-801_775000bc-56de-4c72-87da-65bb33f063b3",
"productndc": "46122-801",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213203",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG;60MG",
"product_no": "001",
"approval_date": "Mar 25, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM;120MG",
"product_no": "002",
"approval_date": "Mar 25, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Guaifenesin and Pseudoephedrine HCl",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA213203",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin and Pseudoephedrine HCl",
"start_marketing_date": "20241001",
"active_numerator_strength": "600; 60"
}Related drugs
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