Home NDC 15370-150-99 RYCLORA
Product NDC 15370-150
Requested package NDC 15370-150-99
11-digit product format 153700150
Labeler code 15370
Product ID 15370-150_3affdd03-252d-443c-9966-e3aec314fb98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexchlorpheniramine Maleate
Dosage form LIQUID
Route ORAL
Labeler CARWIN PHARMACEUTICAL ASSOCIATES, LLC
Application ANDA202520
Marketing category ANDA
Marketing start 2018-10-07
Substance DEXCHLORPHENIRAMINE MALEATE
Active strength 2 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 A202520-001 POLMON DEXCHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP / ORAL RS 2018-07-16
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 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202520-001 POLMON 2MG/5ML SYRUP / ORAL RS 2018-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202520-001 POLMON 2MG/5ML SYRUP / ORAL AA 2018-07-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base RYCLORA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXCHLORPHENIRAMINE MALEATE 2 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B10YD955QW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2183907 Internal RxNorm lookup 2183912 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 15370-150-04 RYCLORA 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 2 15370-150-16 RYCLORA 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 2 15370-150-99 RYCLORA 20 mL in 1 BOTTLE, PLASTIC LIQUID 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 15370-150 RYCLORA (DEXCHLORPHENIRAMINE MALEATE) LIQUID [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] 2 Current NDC, Legacy NDC, 3 package rows 20240109_aa4f80c9-e600-4bc0-8528-02a8162a36f0.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 Marketing end Sample Exclude flag Status 15370-150-99 15370015099 20 mL in 1 BOTTLE, PLASTIC (15370-150-99) 20 ml 2018-10-07 0000-00-00 No No Current