Home NDC 55315-528-31 Loratadine
Product NDC 55315-528
Requested package NDC 55315-528-31
11-digit product format 553150528
Labeler code 55315
Product ID 55315-528_30c112e9-7c17-45cc-829d-d0cceea230c4
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Fred's Inc.
Application ANDA076134
Marketing category ANDA
Marketing start 2003-08-19
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076134-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2003-08-18
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 2 · 25 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55315-528-31 Loratadine 30 in 1 BLISTER PACK TABLET 30 2 55315-528-69 Loratadine 10 in 1 BLISTER PACK TABLET 10 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55315-528 LORATADINE TABLET [FRED'S INC.] 2 Legacy NDC, 2 package rows 20191219_3c7870d7-0f76-49be-bca4-459443ba9467.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-528-31 55315052831 30 TABLET in 1 BLISTER PACK (55315-528-31) 30 tablet 2003-08-19 0000-00-00 No No Current