🇺🇸
United States · US · US:57483-270_77d8fc95-d94b-42f5-97ae-b5ff59ef638b
Crcle Guaifenesin Extended-Release Tablets, 600 mg
Orange BookUNIIATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerInnovus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1157483270015 BLISTER PACK in 1 CARTON (57483-270-01) / 20 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
Raw payload (JSON)
{
"unii": {
"unii": "495W7451VQ",
"rxcui": "5032",
"inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
"display_name": "GUAIFENESIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "57483-270_77d8fc95-d94b-42f5-97ae-b5ff59ef638b",
"productndc": "57483-270",
"dosage_form": "TABLET",
"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": "Crcle Guaifenesin Extended-Release Tablets, 600 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213420",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin Extended-Release",
"start_marketing_date": "20200910",
"active_numerator_strength": "600"
}Related drugs
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