Pseudoephedrine Hydrochloride

Product NDC
37012-204
11-digit product format
370120204
Labeler code
37012
Product ID
37012-204_de0f0d0a-d2aa-4580-bc53-3e26bfde12b5
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
ANDA077442
Marketing category
ANDA
Marketing start
2006-04-28
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
37012-204-202020-01-31C16284748780-19d75b9d0-88b1-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-204-20Pseudoephedrine Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE201

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-204PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SHOPKO STORES OPERATING CO., LLC]1Legacy NDC, 1 package rows20130325_ca6d7a50-3e73-4997-b79d-648a733bf856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNca6d7a50-3e73-4997-b79d-648a733bf8561
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDca6d7a50-3e73-4997-b79d-648a733bf8561
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYca6d7a50-3e73-4997-b79d-648a733bf8561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
37012-204-203701202042020 in 1 BLISTER PACKHistorical