NDC 50090-1106

Sudafed 12 Hour

Pseudoephedrine Hydrochloride

Sudafed 12 Hour is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Pseudoephedrine.

Product ID50090-1106_1866e2e5-4d2b-42ea-ba0f-1ea13172df5a
NDC50090-1106
Product TypeHuman Otc Drug
Proprietary NameSudafed 12 Hour
Generic NamePseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA073585
Labeler NameA-S Medication Solutions
Substance NamePSEUDOEPHEDRINE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-1106-0

1 BLISTER PACK in 1 CARTON (50090-1106-0) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2014-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-1106-0 [50090110600]

Sudafed 12 Hour TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA073585
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-11-28
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

NDC Crossover Matching brand name "Sudafed 12 Hour" or generic name "Pseudoephedrine Hydrochloride"

NDCBrand NameGeneric Name
50090-1106Sudafed 12 HourSudafed 12 Hour
50090-3287SUDAFED 12 HOURSUDAFED 12 HOUR
50580-342SUDAFED 12 HOURSUDAFED 12 HOUR
50580-670Sudafed 12 HourSudafed 12 Hour
0113-205412 hour decongestantPseudoephedrine Hydrochloride
30142-05412 hour decongestantPseudoephedrine Hydrochloride
41250-05412 hour decongestantPseudoephedrine Hydrochloride
41163-054Equaline 12 Hour DecongestantPseudoephedrine Hydrochloride
24385-054good neighbor pharmacy nasal decongestantPseudoephedrine Hydrochloride
0113-0054Good Sense SuphedrinePseudoephedrine Hydrochloride
37205-446Leader 12 Hour Nasal DecongestantPseudoephedrine Hydrochloride
0363-3301Nasal Decongestant DPseudoephedrine Hydrochloride
0363-0204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
0904-6727Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
0904-6728Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
0904-6907Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
21130-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
30142-967Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDE
37012-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
37808-007Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
37808-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
0536-1850RugbyPseudoephedrine Hydrochloride
30142-613sinusPseudoephedrine hydrochloride
0904-5125SudoGestPseudoephedrine Hydrochloride
0904-5803SudoGestPseudoephedrine Hydrochloride
21695-806SudoGestPseudoephedrine Hydrochloride
21695-898SudoGestPseudoephedrine Hydrochloride
33261-651SudoGestPseudoephedrine Hydrochloride
36800-054topcare 12 hour decongestantPseudoephedrine Hydrochloride
0113-0401Zephrex Dpseudoephedrine hydrochloride
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