Home NDC 49483-732 Loratadine 10 mg
Product NDC 49483-732
11-digit product format 494830732
Labeler code 49483
Product ID 49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0
Type HUMAN OTC DRUG
Nonproprietary name Loratadine Tablets USP, 10 mg
Dosage form TABLET
Route ORAL
Labeler TIME CAP LABORATORIES, INC.
Application ANDA219223
Marketing category ANDA
Marketing start 2025-01-25
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 43 .
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 A219223-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2024-11-21
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 2026-09-14 22:38:34 2026-08 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219223-001 LORATADINE 10MG TABLET / ORAL 2024-11-21 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Loratadine 10 mg
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 49483-732-65 Loratadine 10 mg 365 in 1 BOTTLE TABLET 365 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-732 LORATADINE 10 MG (LORATADINE TABLETS USP, 10 MG) TABLET [TIME CAP LABORATORIES, INC.] 1 Current NDC, 1 package rows 20250126_2c80ea14-8490-4d26-e063-6294a90aecf0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49483-732-65 49483073265 365 TABLET in 1 BOTTLE (49483-732-65) 365 tablet 2025-01-25 No No Current