Home NDC 54838-558 Loratadine
Product NDC 54838-558
11-digit product format 548380558
Labeler code 54838
Product ID 54838-558_fd40a94c-2173-4b80-a049-ab3c4faf24f4
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA077421
Marketing category ANDA
Marketing start 2010-11-24
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 A077421-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077421-001 LORATADINE 1MG/ML SYRUP / ORAL 2006-06-29 cb3db0bc1861…
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54838-558-40 Loratadine 120 mL in 1 CARTON SOLUTION 120 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Loratadine ACTIVE INGREDIENT 7AJO3BO7QN LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 Loratadine ACTIVE MOIETY 7AJO3BO7QN LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 glycerin INACTIVE INGREDIENT PDC6A3C0OX LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12 water INACTIVE INGREDIENT 059QF0KO0R LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54838-558 LORATADINE SOLUTION [LANNETT COMPANY, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20220518_069c4e75-1f9f-4ab5-9570-3d93d12c2a23.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 · 4 matching rows.
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 54838-558-40 54838055840 120 mL in 1 CARTON (54838-558-40) 120 ml 2010-11-24 0000-00-00 No No Current