FDA.reportPublic FDA data

12 Hour Nasal Decongestant

Product NDC
70000-0656
11-digit product format
700000656
Labeler code
70000
Product ID
70000-0656_8eaad384-c7af-4263-b948-8623a7c06bcb
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CARDINAL HEALTH
Application
ANDA077442
Marketing category
ANDA
Marketing start
2024-05-16
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
12 Hour Nasal Decongestant
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
70000-0656-112 Hour Nasal Decongestant1 in 1 CARTONTABLET, FILM COATED11
70000-0656-112 Hour Nasal Decongestant10 in 1 BLISTER PACKTABLET, FILM COATED101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0656-1EA - Each70000-0656c5730368-b712-49b7-8117-b48fba05a06e12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-065612 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]1Current NDC, 2 package rows20240523_0ec510e8-a8cf-474b-9da4-2ac5122d6b49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN0ec510e8-a8cf-474b-9da4-2ac5122d6b491
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD0ec510e8-a8cf-474b-9da4-2ac5122d6b491
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY0ec510e8-a8cf-474b-9da4-2ac5122d6b491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0656-1700000656011 BLISTER PACK in 1 CARTON (70000-0656-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-05-16NoNoHistorical