SUDAFED 12 HOUR

Product NDC
50090-3287
11-digit product format
500903287
Labeler code
50090
Product ID
50090-3287_a16e147c-8841-437f-ac0a-f2427eaa8c08
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075153
Marketing category
ANDA
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
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
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
50090-3287-02023-01-30C16284748780-1f386c649-c2ea-0266-e053-dadaa90a7c1aSUDAFED 12 HOUR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3287-0SUDAFED 12 HOUR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE17
50090-3287-0SUDAFED 12 HOUR10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3287SUDAFED 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20200122_da2934cf-4940-4bea-905e-77938be9460d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNda2934cf-4940-4bea-905e-77938be9460d7
1049668SUDAFED 120 MG 12HR Extended Release Oral TabletPSNda2934cf-4940-4bea-905e-77938be9460d7
104966812 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudafed]SBDda2934cf-4940-4bea-905e-77938be9460d7
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDda2934cf-4940-4bea-905e-77938be9460d7
104966812 HR Sudafed 120 MG Extended Release Oral TabletSYda2934cf-4940-4bea-905e-77938be9460d7
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYda2934cf-4940-4bea-905e-77938be9460d7
1049668Sudafed 120 MG 12 HR Extended Release Oral TabletSYda2934cf-4940-4bea-905e-77938be9460d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3287-0500903287001 BLISTER PACK in 1 CARTON (50090-3287-0) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-11-300000-00-00NoNoCurrent