FDA.reportPublic FDA data

Loratadine and Pseudoephedrine

Product NDC
46122-383
11-digit product format
461220383
Labeler code
46122
Product ID
46122-383_39ace1fb-0f76-4ff6-8846-e6316ee972e5
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine and pseudoephedrine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
ANDA076557
Marketing category
ANDA
Marketing start
2017-08-02
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
10; 240 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
Loratadine and Pseudoephedrine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1
PSEUDOEPHEDRINE SULFATE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN, Y9DL7QPE6B
Rxcui1117562

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-383-222021-06-09C16284748780-19d75b9d0-0835-f424-e053-dadaa90a57ceDrug Facts
46122-383-222020-01-31C16284748780-19d75b9d0-0835-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-383-22Loratadine and Pseudoephedrine15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-383-22EA - Each46122-383e37b8f7d-8619-47d4-934e-a56f8f48753c12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-383LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [AMERISOURCE BERGEN]2Current NDC, Legacy NDC, 1 package rows20210610_96635cb0-8c78-4c3a-8294-2804ff26f90a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN96635cb0-8c78-4c3a-8294-2804ff26f90a2
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD96635cb0-8c78-4c3a-8294-2804ff26f90a2
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY96635cb0-8c78-4c3a-8294-2804ff26f90a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-383-224612203832215 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46122-383-22) 2017-08-020000-00-00NoNoCurrent