NDC 58602-811

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 ID58602-811_31db7ce7-45bf-428b-a05d-5fb42244609a
NDC58602-811
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 Strength1200 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58602-811-01

1 BLISTER PACK in 1 CARTON (58602-811-01) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2019-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-811-60 [58602081160]

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

NDC 58602-811-02 [58602081102]

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

NDC 58602-811-57 [58602081157]

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

NDC 58602-811-73 [58602081173]

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

NDC 58602-811-01 [58602081101]

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

NDC 58602-811-56 [58602081156]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210453
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-31

NDC 58602-811-05 [58602081105]

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

NDC 58602-811-21 [58602081121]

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

NDC 58602-811-12 [58602081112]

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

NDC 58602-811-03 [58602081103]

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

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN1200 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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