allergy relief d 12

Product NDC
0363-7023
11-digit product format
003637023
Labeler code
0363
Product ID
0363-7023_d94eb2ec-8cdf-465e-a5f9-db3f8a3e6c1f
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine, Pseudoephedrine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA076050
Marketing category
ANDA
Marketing start
2021-10-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
allergy relief d 12
Listing expiration
2027-12-31

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
0363-7023-46allergy relief d 1210 in 1 CARTONTABLET, FILM COATED, EXTENDED RE104
0363-7023-46allergy relief d 121 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
0363-7023-60allergy relief d 1220 in 1 CARTONTABLET, FILM COATED, EXTENDED RE204
0363-7023-60allergy relief d 121 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
0363-7023-65allergy relief d 121 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
0363-7023-65allergy relief d 1230 in 1 CARTONTABLET, FILM COATED, EXTENDED RE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7023ALLERGY RELIEF D 12 (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [WALGREEN COMPANY]3Current NDC, Legacy NDC, 6 package rows20230907_7e6ea563-cc79-4683-b600-0691e0fb78ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242399pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral TabletPSN7e6ea563-cc79-4683-b600-0691e0fb78ab4
124239912 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCD7e6ea563-cc79-4683-b600-0691e0fb78ab4
1242399loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral TabletSY7e6ea563-cc79-4683-b600-0691e0fb78ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7023-460036370234610 BLISTER PACK in 1 CARTON (0363-7023-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2023-09-06NoNoCurrent
0363-7023-600036370236020 BLISTER PACK in 1 CARTON (0363-7023-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2021-10-200000-00-00NoNoCurrent
0363-7023-650036370236530 BLISTER PACK in 1 CARTON (0363-7023-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2021-10-200000-00-00NoNoCurrent