FDA.reportPublic FDA data

Pseudoephedrine hydrochloride

Product NDC
0904-7409
11-digit product format
009047409
Labeler code
0904
Product ID
0904-7409_1b23c014-95b2-ac65-e063-6294a90a5d5d
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077442
Marketing category
ANDA
Marketing start
2024-06-07
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7409-15Pseudoephedrine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
0904-7409-15Pseudoephedrine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7409-15EA - Each0904-7409d910e2eb-8342-4e83-83f3-328c74d5eb5412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7409PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20240619_658b0fe8-d564-4f79-bbb2-939c518651b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN658b0fe8-d564-4f79-bbb2-939c518651b72
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD658b0fe8-d564-4f79-bbb2-939c518651b72
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY658b0fe8-d564-4f79-bbb2-939c518651b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7409-15009047409151 BLISTER PACK in 1 CARTON (0904-7409-15) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-06-07NoNoCurrent