FDA.reportPublic FDA data

Loratadine and Pseudoephedrine Sulfate

Product NDC
49035-488
11-digit product format
490350488
Labeler code
49035
Product ID
49035-488_32b910db-c0a5-104e-e063-6294a90a3012
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine and Pseudoephedrine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
WAL-MART STORES, INC
Application
ANDA076557
Marketing category
ANDA
Marketing start
2020-06-15
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 Sulfate
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
49035-488-152025-04-14C16284748780-1d6a99b39-aa6e-a426-e053-dadaa90af4c2Loratadine and Pseudoephedrine Sulfate
49035-488-692025-04-14C16284748780-1d6a99b39-aa6e-a426-e053-dadaa90af4c2Loratadine and Pseudoephedrine Sulfate
49035-488-152022-01-28C16284748780-1d6a99b39-aa6e-a426-e053-dadaa90af4c2Loratadine and Pseudoephedrine Sulfate
49035-488-692022-01-28C16284748780-1d6a99b39-aa6e-a426-e053-dadaa90af4c2Loratadine and Pseudoephedrine Sulfate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-488-15Loratadine and Pseudoephedrine Sulfate15 in 1 CARTONTABLET, EXTENDED RELEASE153
49035-488-69Loratadine and Pseudoephedrine Sulfate10 in 1 CARTONTABLET, EXTENDED RELEASE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-488-15EA - Each49035-488c43091b8-a644-405c-a95e-77943001e9be12023-04-07
49035-488-69EA - Each49035-4887907c1e3-d557-424e-8149-ce2dbc611faa12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-488LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]3Current NDC, Legacy NDC, 2 package rows20250416_59453133-20bf-4f13-855a-b47b22302d8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN59453133-20bf-4f13-855a-b47b22302d8b3
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD59453133-20bf-4f13-855a-b47b22302d8b3
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY59453133-20bf-4f13-855a-b47b22302d8b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-488-154903504881515 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-15) 2020-06-150000-00-00NoNoCurrent
49035-488-694903504886910 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-69) 2020-06-150000-00-00NoNoCurrent