Home NDC 17856-0557 Loratadine
Product NDC 17856-0557
11-digit product format 178560557
Labeler code 17856
Product ID 17856-0557_4bc0edf7-fe2e-d8ab-e063-6394a90a8886
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA077421
Marketing category ANDA
Marketing start 2019-02-13
Substance LORATADINE
Active strength 5 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0557-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0557-1 1332a3947898…d4bfe170f9cd…
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 2027-12-31 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0557-1 Loratadine 72 in 1 BOX, UNIT-DOSE SOLUTION 72 5 17856-0557-2 Loratadine 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0557 LORATADINE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20250514_999a1080-5bbd-4027-b6e7-a90a6941ee27.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 17856-0557-1 17856055701 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0557-1) > 5 mL in 1 CUP, UNIT-DOSE 2021-01-22 0000-00-00 No No Current 17856-0557-2 17856055702 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical