Equaline 12 Hour Decongestant

Product NDC
41163-054
11-digit product format
411630054
Labeler code
41163
Product ID
41163-054_8f2a455a-ff19-4cea-8e88-f440971bfe58
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA075153
Marketing category
ANDA
Marketing start
2004-08-10
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
Equaline 12 Hour 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
41163-054-60Equaline 12 Hour Decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
41163-054-60Equaline 12 Hour Decongestant20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-054EQUALINE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 2 package rows20230804_bd5c2093-f812-4dfe-80ea-68cb4e65a09c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNbd5c2093-f812-4dfe-80ea-68cb4e65a09c4
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDbd5c2093-f812-4dfe-80ea-68cb4e65a09c4
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYbd5c2093-f812-4dfe-80ea-68cb4e65a09c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-054-604116300546020 BLISTER PACK in 1 CARTON (41163-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2004-08-100000-00-00NoNoCurrent