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United States · US · US:49483-723_10c427f2-f75b-9e93-e063-6294a90ab0ef
Guaifenesin Extended Release 600 mg
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTIME CAP LABORATORIES, INC.
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114948372350500 TABLET in 1 BOTTLE (49483-723-50)
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A217780
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": "49483-723_10c427f2-f75b-9e93-e063-6294a90ab0ef",
"productndc": "49483-723",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217780",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Aug 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "Aug 21, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "Guaifenesin Extended Release 600 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217780",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20240108",
"active_numerator_strength": "600"
}Related drugs
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