FDA.reportPublic FDA data

Pseudoephedrine Hydrochloride

Product NDC
58602-884
11-digit product format
586020884
Labeler code
58602
Product ID
58602-884_77e4132e-470e-4fb4-bc2f-df2e59061ba9
Type
HUMAN OTC DRUG
Nonproprietary name
pseudoephedrine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA218854
Marketing category
ANDA
Marketing start
2025-12-29
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
240 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 HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049670

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
58602-884-27Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, EXTENDED RELEASE11
58602-884-27Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101
58602-884-58Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE51
58602-884-58Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, EXTENDED RELEASE21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049670pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN77e4132e-470e-4fb4-bc2f-df2e59061ba91
104967024 HR pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD77e4132e-470e-4fb4-bc2f-df2e59061ba91
1049670pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY77e4132e-470e-4fb4-bc2f-df2e59061ba91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-884-27586020884271 BLISTER PACK in 1 CARTON (58602-884-27) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2025-12-29NoNoCurrent
58602-884-58586020884582 BLISTER PACK in 1 CARTON (58602-884-58) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-12-29NoNoCurrent