FDA.reportPublic FDA data

SudoGest

Product NDC
52959-260
11-digit product format
529590260
Labeler code
52959
Product ID
52959-260_68ccbad3-6dd8-41d3-8eb2-7babb7d1a44a
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, 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
52959-260-002019-11-13C16284748780-197449f38-d544-f6ea-e053-dbdaa90aa703SudoGest Nasal Decongestant
52959-260-202019-11-13C16284748780-197449f38-d544-f6ea-e053-dbdaa90aa703SudoGest Nasal Decongestant
52959-260-242019-11-13C16284748780-197449f38-d544-f6ea-e053-dbdaa90aa703SudoGest Nasal Decongestant
52959-260-252019-11-13C16284748780-197449f38-d544-f6ea-e053-dbdaa90aa703SudoGest Nasal Decongestant
52959-260-302019-11-13C16284748780-197449f38-d544-f6ea-e053-dbdaa90aa703SudoGest Nasal Decongestant
52959-260-402019-11-13C16284748780-197449f38-d544-f6ea-e053-dbdaa90aa703SudoGest Nasal Decongestant
52959-260-602019-11-13C16284748780-197449f38-d544-f6ea-e053-dbdaa90aa703SudoGest Nasal Decongestant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-260-00SudoGest100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
52959-260-20SudoGest20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
52959-260-24SudoGest24 in 1 BOTTLE, PLASTICTABLET, FILM COATED242
52959-260-25SudoGest25 in 1 BOTTLE, PLASTICTABLET, FILM COATED252
52959-260-30SudoGest30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
52959-260-40SudoGest40 in 1 BOTTLE, PLASTICTABLET, FILM COATED402
52959-260-60SudoGest60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-260-00EA - Each52959-260dbc74f60-b33b-4ddd-ad2c-c0d44ff74c9612012-07-24
52959-260-20EA - Each52959-26001d4c7c9-7d60-4120-b00f-9ba3afb0019012012-07-24
52959-260-24EA - Each52959-260afea45be-f83b-4179-bdef-8e24eea7bfd812012-07-24
52959-260-25EA - Each52959-260e3887d04-ae08-41c0-be12-2bb2beb3360912012-07-24
52959-260-30EA - Each52959-260a2cfc6ff-fbf1-4f0b-ab60-d9c4824d0db112012-07-24
52959-260-40EA - Each52959-26095e5bace-c2f5-4efc-9d1b-4b9e9ce8b04012012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-260SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 7 package rows20120120_f2ef2293-8d05-44ee-987d-898a72eb5735.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049167pseudoephedrine HCl 60 MG Oral TabletPSNf2ef2293-8d05-44ee-987d-898a72eb57352
1049169SudoGest 60 MG Oral TabletPSNf2ef2293-8d05-44ee-987d-898a72eb57352
1049169pseudoephedrine hydrochloride 60 MG Oral Tablet [Sudogest]SBDf2ef2293-8d05-44ee-987d-898a72eb57352
1049167pseudoephedrine hydrochloride 60 MG Oral TabletSCDf2ef2293-8d05-44ee-987d-898a72eb57352
1049169Sudogest 60 MG Oral TabletSYf2ef2293-8d05-44ee-987d-898a72eb57352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-260-0052959026000100 in 1 BOTTLE, PLASTICHistorical
52959-260-205295902602020 in 1 BOTTLE, PLASTICHistorical
52959-260-245295902602424 in 1 BOTTLE, PLASTICHistorical
52959-260-255295902602525 in 1 BOTTLE, PLASTICHistorical
52959-260-305295902603030 in 1 BOTTLE, PLASTICHistorical
52959-260-405295902604040 in 1 BOTTLE, PLASTICHistorical
52959-260-605295902606060 in 1 BOTTLE, PLASTICHistorical