pseudoephedrine hydrochloride

Product NDC
50090-5615
11-digit product format
500905615
Labeler code
50090
Product ID
50090-5615_32a348b0-eed2-48cf-b609-cc7e7ea19e08
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-10-17
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
pseudoephedrine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049160

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5615-0pseudoephedrine hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED110
50090-5615-0pseudoephedrine hydrochloride48 in 1 CARTONTABLET, FILM COATED4810
50090-5615-1pseudoephedrine hydrochloride24 in 1 CARTONTABLET, FILM COATED2410
50090-5615-1pseudoephedrine hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5615PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 4 package rows20231130_204849d1-ac4b-4dbe-8769-fcb30291f880.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN204849d1-ac4b-4dbe-8769-fcb30291f88010
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD204849d1-ac4b-4dbe-8769-fcb30291f88010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5615-05009056150024 BLISTER PACK in 1 CARTON (50090-5615-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2021-08-230000-00-00NoNoCurrent
50090-5615-15009056150124 BLISTER PACK in 1 CARTON (50090-5615-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2021-08-230000-00-00NoNoCurrent