NDC 51660-058

Guaifenesin and Pseudoephedrine HCl

Guaifenesin And Pseudoephedrine Hcl

Guaifenesin and Pseudoephedrine HCl is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Ohm Laboratories, Inc.. The primary component is Guaifenesin; Pseudoephedrine.

Product ID51660-058_efb49ad2-ac54-4918-9c5a-7228a6dfa21c
NDC51660-058
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Pseudoephedrine HCl
Generic NameGuaifenesin And Pseudoephedrine Hcl
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-04-01
Marketing CategoryANDA /
Application NumberANDA212542
Labeler NameOhm Laboratories, Inc.
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE
Active Ingredient Strength600 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51660-058-18

1 BLISTER PACK in 1 CARTON (51660-058-18) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2021-04-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Guaifenesin and Pseudoephedrine HCl" or generic name "Guaifenesin And Pseudoephedrine Hcl"

NDCBrand NameGeneric Name
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
0363-9946Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
11822-0046Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCL
30142-137Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
51660-057Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
51660-058Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
55111-798Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCL
55111-799Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCL
58602-833Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
58602-834Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
70677-0110Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCL
79481-1002Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
49035-261Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mgGuaifenesin and Pseudoephedrine HCL
0363-1604Mucus Relief DGuaifenesin and Pseudoephedrine HCL
0363-7064Mucus Relief DGuaifenesin and Pseudoephedrine HCL
11822-7399Mucus Relief DGuaifenesin and Pseudoephedrine HCL
69842-211Mucus Relief DGuaifenesin and Pseudoephedrine HCL
70000-0608Mucus Relief DGuaifenesin and Pseudoephedrine HCL
50991-212Poly-Vent IRGuaifenesin and Pseudoephedrine HCl

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.