FDA.reportPublic FDA data

SudoGest

Product NDC
66336-096
11-digit product format
663360096
Labeler code
66336
Product ID
66336-096_7b4582e6-e63b-49a6-ab60-608ef3897946
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1994-10-01
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-096-202019-10-29C16284748780-1960f7f55-c12e-8e05-e053-dbdaa90a074aSudoGest Nasal Decongestant
66336-096-302019-10-29C16284748780-1960f7f55-c12e-8e05-e053-dbdaa90a074aSudoGest Nasal Decongestant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-096-20SudoGest20 in 1 BOTTLE, PLASTICTABLET202
66336-096-30SudoGest30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-096-30EA - Each66336-096b0c7f02a-3ee3-489d-b6da-92d2e5bbb11212013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-096SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 2 package rows20110916_b34f64ed-7c56-4c6f-97de-2d6e1bf78406.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049167pseudoephedrine HCl 60 MG Oral TabletPSNb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049169SudoGest 60 MG Oral TabletPSNb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBDb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCDb34f64ed-7c56-4c6f-97de-2d6e1bf784062
1049169Sudogest 60 MG Oral TabletSYb34f64ed-7c56-4c6f-97de-2d6e1bf784062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-096-206633600962020 in 1 BOTTLE, PLASTICHistorical
66336-096-306633600963030 in 1 BOTTLE, PLASTICHistorical