FDA.reportPublic FDA data

Mucinex D

Product NDC
68258-3035
11-digit product format
682583035
Labeler code
68258
Product ID
68258-3035_f7d4a75c-bde1-4166-b6f8-70b8df2e7fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions Inc.
Application
NDA021585
Marketing category
NDA
Marketing start
2008-02-08
Marketing end
0000-00-00
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
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
68258-3035-12019-10-21C16284748780-1956f9ecf-bbce-621f-e053-dbdaa90a74adMucinex®D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3035-1Mucinex D9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE91
68258-3035-1Mucinex D2 in 1 CARTONTABLET, EXTENDED RELEASE21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3035MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1Legacy NDC, 2 package rows20100303_98149172-3ec7-4212-9a37-5501bbfb5829.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN98149172-3ec7-4212-9a37-5501bbfb58291
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD98149172-3ec7-4212-9a37-5501bbfb58291
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY98149172-3ec7-4212-9a37-5501bbfb58291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-3035-1682583035019 in 1 BLISTER PACKHistorical