equate sinus 12 hour

Product NDC
49035-508
11-digit product format
490350508
Labeler code
49035
Product ID
49035-508_8c5a871b-8040-43a0-ab1a-dda08929fdce
Type
HUMAN OTC DRUG
Nonproprietary name
pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA075153
Marketing category
ANDA
Marketing start
2020-06-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
equate sinus 12 hour
Listing expiration
2027-12-31

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
49035-508-60equate sinus 12 hour1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
49035-508-60equate sinus 12 hour20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-508EQUATE SINUS 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WAL-MART STORES INC]2Current NDC, Legacy NDC, 2 package rows20200707_de65b99e-85e9-46c1-88b2-727c7ed8882a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNde65b99e-85e9-46c1-88b2-727c7ed8882a3
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDde65b99e-85e9-46c1-88b2-727c7ed8882a3
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYde65b99e-85e9-46c1-88b2-727c7ed8882a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-508-604903505086020 BLISTER PACK in 1 CARTON (49035-508-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2020-06-240000-00-00NoNoCurrent