Home NDC 70000-0125 Loratadine
Product NDC 70000-0125
11-digit product format 700000125
Labeler code 70000
Product ID 70000-0125_88e1fe57-4ad1-4646-b639-e935285aec4b
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health, 110 dba LEADER
Application ANDA076805
Marketing category ANDA
Marketing start 2004-08-20
Substance LORATADINE
Active strength 5 mg/5mL
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 A076805-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20
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 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 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 1 · 15 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 5 mg/5mL
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 692783 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 70000-0125-1 Loratadine 118 mL in 1 BOTTLE SOLUTION 118 3 70000-0125-1 Loratadine 1 in 1 CARTON SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0125 LORATADINE SOLUTION [CARDINAL HEALTH, 110 DBA LEADER] 3 Current NDC, Legacy NDC, 2 package rows 20210626_db9d2182-6bf1-424a-a144-f2694c47989f.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 70000-0125-1 70000012501 1 BOTTLE in 1 CARTON (70000-0125-1) / 118 mL in 1 BOTTLE 1 bottle 2016-10-24 0000-00-00 No No Current