Home NDC 11523-0104 Claritin
Product NDC 11523-0104
11-digit product format 115230104
Labeler code 11523
Product ID 11523-0104_4526d753-7999-0ec3-e063-6294a90a270f
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Bayer HealthCare LLC.
Application ANDA210033
Marketing category ANDA
Marketing start 2023-02-05
Substance LORATADINE
Active strength 5 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 42 .
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 A210033-001 LORATADINE LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210033-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2019-06-12 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Claritin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 665078 Internal RxNorm lookup 668469 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 11523-0104-1 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 17 11523-0104-1 Claritin 1 in 1 CARTON TABLET, CHEWABLE 1 17 11523-0104-2 Claritin 2 in 1 CARTON TABLET, CHEWABLE 2 17 11523-0104-2 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 17 11523-0104-3 Claritin 3 in 1 CARTON TABLET, CHEWABLE 3 17 11523-0104-3 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 17 11523-0104-4 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 17 11523-0104-4 Claritin 4 in 1 CARTON TABLET, CHEWABLE 4 17 11523-0104-5 Claritin 6 in 1 CARTON TABLET, CHEWABLE 6 17 11523-0104-5 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 17 11523-0104-6 Claritin 8 in 1 CARTON TABLET, CHEWABLE 8 17 11523-0104-6 Claritin 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-0104 CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.] 16 Current NDC, 12 package rows 20241208_f3b9c643-a605-7702-e053-2995a90a6130.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 · 13 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 11523-0104-1 11523010401 1 BLISTER PACK in 1 CARTON (11523-0104-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 1 blister pack 2023-02-08 No No Current 11523-0104-2 11523010402 2 BLISTER PACK in 1 CARTON (11523-0104-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2023-02-08 No No Current 11523-0104-3 11523010403 3 BLISTER PACK in 1 CARTON (11523-0104-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2023-02-08 No No Current 11523-0104-4 11523010404 4 BLISTER PACK in 1 CARTON (11523-0104-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 4 blister pack 2023-02-08 No No Current 11523-0104-5 11523010405 6 BLISTER PACK in 1 CARTON (11523-0104-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 6 blister pack 2023-02-08 No No Current 11523-0104-6 11523010406 8 BLISTER PACK in 1 CARTON (11523-0104-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 8 blister pack 2023-02-05 No No Current