CLARINEX-D 12 HOUR

Product NDC
0085-1322
11-digit product format
000851322
Labeler code
0085
Product ID
0085-1322_14500ece-eea2-4589-8278-fbce510c7c7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desloratadine and pseudoephedrine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA021313
Marketing category
NDA
Marketing start
2006-02-01
Marketing end
0000-00-00
Substance
DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
01632a31-f1c5-44ea-aa59-efded68c0797Product name120150716
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
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-1322-01EA - Each0085-1322af15910f-fd4a-4170-a0b9-cdf8911517ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESLORATADINEACTIVE INGREDIENTFVF865388RCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
DESLORATADINEACTIVE MOIETYFVF865388RCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112250CLARINEX-D 2.5 MG / 120 MG 12HR Extended Release Oral TabletPSNc7230a68-a3ac-4dce-9e72-6e21f0b25f451
1112248desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG 12HR Extended Release Oral TabletPSNc7230a68-a3ac-4dce-9e72-6e21f0b25f451
111225012 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Clarinex-D]SBDc7230a68-a3ac-4dce-9e72-6e21f0b25f451
111224812 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCDc7230a68-a3ac-4dce-9e72-6e21f0b25f451
1112250Clarinex-D (desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral TabletSYc7230a68-a3ac-4dce-9e72-6e21f0b25f451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0085-1322-0100085132201100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0085-1322-01) 2006-02-010000-00-00NoNoCurrent