Home NDC 63941-526 Loratadine
Product NDC 63941-526
11-digit product format 639410526
Labeler code 63941
Product ID 63941-526_bc05aca7-4224-4b42-93b7-d28fbf18c0b1
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Valu Merchandisers Company
Application ANDA076134
Marketing category ANDA
Marketing start 2003-08-19
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Loratadine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AJO3BO7QN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311372 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63941-526-31 Loratadine 30 in 1 BLISTER PACK TABLET 30 2 63941-526-60 Loratadine 60 in 1 BOTTLE TABLET 60 2 63941-526-69 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 63941-526 LORATADINE TABLET [VALU MERCHANDISERS COMPANY] 2 Current NDC, Legacy NDC, 3 package rows 20180829_0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8.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 63941-526-31 63941052631 30 TABLET in 1 BLISTER PACK (63941-526-31) 30 tablet 2003-08-19 0000-00-00 No No Current 63941-526-60 63941052660 60 TABLET in 1 BOTTLE (63941-526-60) 60 tablet 2003-08-19 0000-00-00 No No Current 63941-526-69 63941052669 10 TABLET in 1 BLISTER PACK (63941-526-69) 10 tablet 2003-08-19 0000-00-00 No No Current