Home NDC 74157-011 Desloratadine Oral Solution
Product NDC 74157-011
11-digit product format 741570011
Labeler code 74157
Product ID 74157-011_41d5e0d4-6189-847b-e063-6294a90a2e2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desloratadine
Dosage form SOLUTION
Route ORAL
Labeler INA Pharmaceutics, Inc.
Application ANDA202936
Marketing category ANDA
Marketing start 2025-07-01
Substance DESLORATADINE
Active strength .5 mg/mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 A202936-001 DESLORATADINE DESLORATADINE 0.5MG/ML SOLUTION / ORAL RS 2016-05-26
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 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL RS 2016-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL RS 2016-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL RS 2016-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL AA 2016-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL AA 2016-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL AA 2016-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL AA 2016-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL AA 2016-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL AA 2016-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202936-001 DESLORATADINE 0.5MG/ML SOLUTION / ORAL 2016-05-26 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Desloratadine Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESLORATADINE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FVF865388R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 607573 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 74157-011-01 Desloratadine Oral Solution 118 mL in 1 BOTTLE SOLUTION 118 1
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 · 1 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 74157-011-01 74157001101 118 mL in 1 BOTTLE (74157-011-01) 118 ml 2025-07-01 No No Current