NDC 58602-810

Guaifenesin

Guaifenesin

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

Product ID58602-810_1c674a36-f89b-4a65-915d-30f79e1b6f21
NDC58602-810
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-10-21
Marketing CategoryANDA / ANDA
Application NumberANDA210453
Labeler NameAurohealth LLC
Substance NameGUAIFENESIN
Active Ingredient Strength600 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58602-810-12

1 BOTTLE in 1 CARTON (58602-810-12) > 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2019-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-810-73 [58602081073]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210453
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-21

NDC 58602-810-21 [58602081021]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210453
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-21

NDC 58602-810-98 [58602081098]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210453
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-21

NDC 58602-810-96 [58602081096]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210453
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-21

NDC 58602-810-12 [58602081012]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210453
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-21

NDC 58602-810-97 [58602081097]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210453
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

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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