Home NDC 43547-409 PAROXETINE
Product NDC 43547-409
11-digit product format 435470409
Labeler code 43547
Product ID 43547-409_30b0c2b9-fb81-4015-ad28-12e658de0dea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine
Dosage form CAPSULE
Route ORAL
Labeler Solco Healthcare LLC
Application ANDA207188
Marketing category ANDA
Marketing start 2017-08-15
Substance PAROXETINE MESYLATE
Active strength 7.5 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A207188-001 PAROXETINE MESYLATE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207188-001 AB
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 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207188-001 PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB 2017-08-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PAROXETINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE MESYLATE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M711N184JE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1430122 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 43547-409-03 PAROXETINE 30 in 1 BOTTLE CAPSULE 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-409 PAROXETINE CAPSULE [SOLCO HEALTHCARE LLC] 2 Current NDC, Legacy NDC, 1 package rows 20210618_2c5836c3-2099-452e-b6af-d2d50dc359fd.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 · 1 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 43547-409-03 43547040903 30 CAPSULE in 1 BOTTLE (43547-409-03) 30 capsule 2017-08-15 0000-00-00 No No Current