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United States · US · US:55111-798_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd
Guaifenesin and Pseudoephedrine HCL
Orange BookUNIISPLATC R05CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddys Laboratories Limited
CountryUS (United States)
ATC codeR05CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1155111798091 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111798182 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111798351 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111798364 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111798412 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A208369
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": "55111-798_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd",
"productndc": "55111-798",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208369",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG;60MG",
"product_no": "001",
"approval_date": "Dec 29, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM;120MG",
"product_no": "002",
"approval_date": "Dec 29, 2017"
}
],
"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": "ANDA208369",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin and Pseudoephedrine HCL",
"start_marketing_date": "20171229",
"active_numerator_strength": "600; 60"
}Related drugs
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