ED-A-HIST PSE

Product NDC
0485-0210
11-digit product format
004850210
Labeler code
0485
Product ID
0485-0210_d57f830b-52d0-0fd2-e053-2995a90a8a7a
Type
HUMAN OTC DRUG
Nonproprietary name
PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
EDWARDS PHARMACEUTICALS, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-08
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
60 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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
0485-0210-012023-07-28C16284748780-19d75b9d0-b44f-f424-e053-dadaa90a57ceED-A-HIST PSE TABLETS
0485-0210-012020-04-08C16284748780-19d75b9d0-b44f-f424-e053-dadaa90a57ceED-A-HIST PSE TABLETS
0485-0210-012020-01-31C16284748780-19d75b9d0-b44f-f424-e053-dadaa90a57ceED-A-HIST PSE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0485-0210-01ED-A-HIST PSE100 in 1 BOTTLE, PLASTICTABLET, COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0485-0210-01EA - Each0485-0210f081f567-3afd-4a8b-91e8-ec804467110612013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
TRIPROLIDINE HYDROCHLORIDEACTIVE INGREDIENTYAN7R5L890ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
TRIPROLIDINEACTIVE MOIETY2L8T9S52QMED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0485-0210ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]4Legacy NDC, 1 package rows20220114_b0c6ef78-0f82-4ff7-a988-b11f99094843.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099446pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral TabletPSNb0c6ef78-0f82-4ff7-a988-b11f990948434
1099446pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral TabletSCDb0c6ef78-0f82-4ff7-a988-b11f990948434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0485-0210-0100485021001100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01) 2011-10-080000-00-00NoNoCurrent