FDA.reportPublic FDA data

Pseudoephedrine hydrochloride

Product NDC
50090-5554
11-digit product format
500905554
Labeler code
50090
Product ID
50090-5554_3b6c8d9e-78df-44be-9bc6-052e19f97706
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077442
Marketing category
ANDA
Marketing start
2006-04-28
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pseudoephedrine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049154

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
50090-5554-02023-02-07C16284748780-1f386c649-9ef4-0266-e053-dadaa90a7c1aPseudoephedrine hydrochloride
50090-5554-02023-02-07C16284748780-1f386c649-9ef4-0266-e053-dadaa90a7c1aPseudoephedrine hydrochloride
50090-5554-02023-01-30C16284748780-1f386c649-9ef4-0266-e053-dadaa90a7c1aPseudoephedrine hydrochloride
50090-5554-02023-01-30C16284748780-1f386c649-9ef4-0266-e053-dadaa90a7c1aPseudoephedrine hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5554-0Pseudoephedrine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5554-0EA - Each50090-5554d9f8acbe-691a-46af-ad68-b498d53341ce12023-10-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN0a2672f0-4e6f-48c9-8571-2d09f06253d75
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD0a2672f0-4e6f-48c9-8571-2d09f06253d75
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY0a2672f0-4e6f-48c9-8571-2d09f06253d75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5554-05009055540010 TABLET, FILM COATED in 1 BLISTER PACK (50090-5554-0) 2021-06-140000-00-00NoNoCurrent