NDC 71309-461

GUAIFENESIN

Guaifenesin

GUAIFENESIN is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Safrel Pharmaceuticals, Llc.. The primary component is Guaifenesin.

Product ID71309-461_e2a3c17c-6c9a-51eb-e053-2a95a90afb08
NDC71309-461
Product TypeHuman Otc Drug
Proprietary NameGUAIFENESIN
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-12-18
Marketing CategoryANDA /
Application NumberANDA213420
Labeler NameSafrel Pharmaceuticals, LLC.
Substance NameGUAIFENESIN
Active Ingredient Strength1200 mg/1
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71309-461-56

56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-461-56)
Marketing Start Date2022-06-29
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "GUAIFENESIN" or generic name "Guaifenesin"

NDCBrand NameGeneric Name
0121-0744GUAIFENESINGUAIFENESIN
0121-1488GUAIFENESINGUAIFENESIN
0121-1744GUAIFENESINGUAIFENESIN
0121-2232GUAIFENESINGUAIFENESIN
0363-0028GuaifenesinGuaifenesin
0363-0033GuaifenesinGuaifenesin
70000-0106GuaifenesinGuaifenesin
70518-1782GuaifenesinGuaifenesin
0904-5154GuaifenesinGuaifenesin
15338-769GuaifenesinGuaifenesin
30142-703GuaifenesinGuaifenesin
42291-313GuaifenesinGuaifenesin
49349-511GuaifenesinGuaifenesin
50383-063GuaifenesinGuaifenesin
51660-070GUAIFENESINGUAIFENESIN
55154-5780GUAIFENESINGUAIFENESIN
55154-9437GuaifenesinGuaifenesin
58657-509GuaifenesinGuaifenesin
65162-037GuaifenesinGuaifenesin
65162-036GuaifenesinGuaifenesin
67046-251GuaifenesinGuaifenesin
55154-9450GUAIFENESINGUAIFENESIN
58602-810GuaifenesinGuaifenesin
58602-811GuaifenesinGuaifenesin
62207-569GUAIFENESINGUAIFENESIN
79395-001GuaifenesinGuaifenesin
69618-061GuaifenesinGuaifenesin
58602-853GuaifenesinGuaifenesin
63629-1156GuaifenesinGuaifenesin
62207-839GUAIFENESINGUAIFENESIN
62207-840GUAIFENESINGUAIFENESIN
0363-0288childrens chest congestionGuaifenesin
0113-0325Good Sense Mucus ERGuaifenesin
0113-2023good sense mucus erguaifenesin
0113-3650Good Sense Mucus ERGuaifenesin
0113-0061good sense tussinGuaifenesin
0363-0071MucusGuaifenesin
0363-0074MucusGuaifenesin
0363-0532Mucus ReliefGuaifenesin
0363-0325mucus relief erGuaifenesin
0031-9303Robitussin Direct Chest Congestionguaifenesin
0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
0113-2061tussinGuaifenesin
0363-0310wal tussinGuaifenesin
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