signature care allergy and congestion relief

Product NDC
21130-482
11-digit product format
211300482
Labeler code
21130
Product ID
21130-482_35ee6029-73f0-4239-9983-a1af2565c005
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine, Pseudoephedrine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Safeway
Application
ANDA076050
Marketing category
ANDA
Marketing start
2018-04-02
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
5; 120 mg/1; 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
signature care allergy and congestion relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1
PSEUDOEPHEDRINE SULFATE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN, Y9DL7QPE6B
Rxcui1242399

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
21130-482-60signature care allergy and congestion relief1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE15
21130-482-60signature care allergy and congestion relief20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-482SIGNATURE CARE ALLERGY AND CONGESTION RELIEF (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY]5Current NDC, Legacy NDC, 2 package rows20210311_e1993d05-248e-48da-838c-068f8263c2eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242399pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral TabletPSNe1993d05-248e-48da-838c-068f8263c2eb5
124239912 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCDe1993d05-248e-48da-838c-068f8263c2eb5
1242399loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral TabletSYe1993d05-248e-48da-838c-068f8263c2eb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-482-602113004826020 BLISTER PACK in 1 CARTON (21130-482-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2018-04-020000-00-00NoNoCurrent