🇺🇸
United States · US · US:53041-234_8186c3e8-1ae5-459d-8771-ad2d1ae95387
Guaifenesin Extended-Release 1200 mg
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGuardian Drug Company
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1153041234374 BLISTER PACK in 1 CARTON (53041-234-37) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1153041234476 BLISTER PACK in 1 CARTON (53041-234-47) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1153041234582 BLISTER PACK in 1 CARTON (53041-234-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A209215
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": "53041-234_8186c3e8-1ae5-459d-8771-ad2d1ae95387",
"productndc": "53041-234",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209215",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Sep 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "Sep 6, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "Guaifenesin Extended-Release 1200 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209215",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20180301",
"active_numerator_strength": "1200"
}Related drugs
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