FDA.reportPublic FDA data

nasal decongestant

Product NDC
42254-359
11-digit product format
422540359
Labeler code
42254
Product ID
42254-359_83ae6177-afbb-477f-a5ff-64d48960ffef
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075153
Marketing category
ANDA
Marketing start
1999-08-12
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 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
42254-359-102019-09-24C16284748780-19350213a-3dbe-c013-e053-90daa90a1393Nasal Decongestant Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-359-10nasal decongestant1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE11
42254-359-10nasal decongestant10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-359NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130329_83ae6177-afbb-477f-a5ff-64d48960ffef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN83ae6177-afbb-477f-a5ff-64d48960ffef1
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD83ae6177-afbb-477f-a5ff-64d48960ffef1
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY83ae6177-afbb-477f-a5ff-64d48960ffef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-359-10422540359101 in 1 CARTONHistorical