FDA.reportPublic FDA data

Pseudoephedrine Hydrochloride

Product NDC
70000-0601
11-digit product format
700000601
Labeler code
70000
Product ID
70000-0601_604a27bc-af28-4609-a9a2-33c2c60e090a
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC DBA LEADER
Application
ANDA077442
Marketing category
ANDA
Marketing start
2022-03-09
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
70000-0601-1Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET12
70000-0601-1Pseudoephedrine Hydrochloride20 in 1 BLISTER PACKTABLET202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0601-1EA - Each70000-0601638735d8-a61b-4071-8a49-2b0e8fb3e27012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0601PSEUDOEPHEDRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 110, LLC DBA LEADER]2Current NDC, Legacy NDC, 2 package rows20220518_a2189d7d-9335-4e96-8f6d-95c583739ac0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNa2189d7d-9335-4e96-8f6d-95c583739ac02
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDa2189d7d-9335-4e96-8f6d-95c583739ac02
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYa2189d7d-9335-4e96-8f6d-95c583739ac02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0601-1700000601011 BLISTER PACK in 1 CARTON (70000-0601-1) / 20 TABLET in 1 BLISTER PACK1 blister pack2022-03-090000-00-00NoNoCurrent