🇺🇸
United States · US · US:43598-008_cdb94f95-f037-62cc-0d37-2b8c5ea26ca4
Guaifenesin 600 mg
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1143598008015 BLISTER PACK in 1 CARTON (43598-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20)
- ndc1143598008402 BLISTER PACK in 1 CARTON (43598-008-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20)
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A215932
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": "43598-008_cdb94f95-f037-62cc-0d37-2b8c5ea26ca4",
"productndc": "43598-008",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215932",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Mar 15, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "Mar 15, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "Guaifenesin 600 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215932",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20220315",
"active_numerator_strength": "600"
}Related drugs
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