Good Sense Suphedrine

Product NDC
0113-0054
11-digit product format
001130054
Labeler code
0113
Product ID
0113-0054_c6732f48-a888-4421-9598-d664999f40c3
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA075153
Marketing category
ANDA
Marketing start
1999-10-29
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense Suphedrine
Brand name suffix
12 Hour
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049154

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0054-52Good Sense Suphedrine12 Hour1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
0113-0054-52Good Sense Suphedrine12 Hour10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0054-52EA - Each0113-00543f2d453f-4fe2-45b0-9e75-e9e38efa98da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0054GOOD SENSE SUPHEDRINE 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 2 package rows20190515_1de8a7f6-e7bb-437d-8794-c4b9f43b89c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN1de8a7f6-e7bb-437d-8794-c4b9f43b89c94
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD1de8a7f6-e7bb-437d-8794-c4b9f43b89c94
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY1de8a7f6-e7bb-437d-8794-c4b9f43b89c94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0054-520011300545210 BLISTER PACK in 1 CARTON (0113-0054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack1999-10-290000-00-00NoNoCurrent