FDA.reportPublic FDA data

SudoGest

Product NDC
0904-5125
11-digit product format
009045125
Labeler code
0904
Product ID
0904-5125_6d4fe6b4-b503-4414-8a81-781f90217d97
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1984-12-07
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5125-46EA - Each0904-51253623143d-f36f-4353-b277-45df0227800412012-07-24
0904-5125-59EA - Each0904-51253d202d8d-4e7e-45a3-ae64-7fa3baa531f112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]3
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NPSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FPSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049167pseudoephedrine HCl 60 MG Oral TabletPSN065ad37b-5200-4b45-a626-4b29452b4ec717
1049169SudoGest 60 MG Oral TabletPSN065ad37b-5200-4b45-a626-4b29452b4ec717
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBD065ad37b-5200-4b45-a626-4b29452b4ec717
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCD065ad37b-5200-4b45-a626-4b29452b4ec717
1049169Sudogest 60 MG Oral TabletSY065ad37b-5200-4b45-a626-4b29452b4ec717
1049167pseudoephedrine HCl 60 MG Oral TabletPSN9044cb58-0386-44a8-ba27-bd205aa99fb45
1049169SudoGest 60 MG Oral TabletPSN9044cb58-0386-44a8-ba27-bd205aa99fb45
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBD9044cb58-0386-44a8-ba27-bd205aa99fb45
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCD9044cb58-0386-44a8-ba27-bd205aa99fb45
1049169Sudogest 60 MG Oral TabletSY9044cb58-0386-44a8-ba27-bd205aa99fb45
1049167pseudoephedrine HCl 60 MG Oral TabletPSNb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049167pseudoephedrine HCl 60 MG Oral TabletPSNf2ef2293-8d05-44ee-987d-898a72eb57352
1049167pseudoephedrine HCl 60 MG Oral TabletPSN7d26821c-a08a-40a8-9729-251f21d547022
1049169SudoGest 60 MG Oral TabletPSN7d26821c-a08a-40a8-9729-251f21d547022
1049169SudoGest 60 MG Oral TabletPSNb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049169SudoGest 60 MG Oral TabletPSNf2ef2293-8d05-44ee-987d-898a72eb57352
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBDf2ef2293-8d05-44ee-987d-898a72eb57352
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBDb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBD7d26821c-a08a-40a8-9729-251f21d547022
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCDb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCD7d26821c-a08a-40a8-9729-251f21d547022
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCDf2ef2293-8d05-44ee-987d-898a72eb57352
1049169Sudogest 60 MG Oral TabletSYb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049169Sudogest 60 MG Oral TabletSY7d26821c-a08a-40a8-9729-251f21d547022
1049169Sudogest 60 MG Oral TabletSYf2ef2293-8d05-44ee-987d-898a72eb57352
1049167pseudoephedrine HCl 60 MG Oral TabletPSNc7eece80-2d36-4aec-89d7-4924ab2aeb921
1049167pseudoephedrine HCl 60 MG Oral TabletPSNf709661d-ae6d-408a-9701-187f7f6f3fc61
1049169SudoGest 60 MG Oral TabletPSNc7eece80-2d36-4aec-89d7-4924ab2aeb921
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBDc7eece80-2d36-4aec-89d7-4924ab2aeb921
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCDc7eece80-2d36-4aec-89d7-4924ab2aeb921
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCDf709661d-ae6d-408a-9701-187f7f6f3fc61
1049169Sudogest 60 MG Oral TabletSYc7eece80-2d36-4aec-89d7-4924ab2aeb921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-5125-460090451254630 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0904-5125-46) 1984-12-070000-00-00NoNoCurrent
0904-5125-59009045125591 BOTTLE, PLASTIC in 1 CARTON (0904-5125-59) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1984-12-072021-11-26NoNoCurrent