Home NDC 35573-439 Loxapine
Product NDC 35573-439
11-digit product format 355730439
Labeler code 35573
Product ID 35573-439_8beb166a-d8f6-4b77-b191-3d7f5699a6f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loxapine
Dosage form CAPSULE
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA076868
Marketing category ANDA
Marketing start 2021-05-01
Marketing end 0000-00-00
Substance LOXAPINE SUCCINATE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 20 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35573-439-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 35573-439-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 35573-439-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 35573-439-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 35573-439-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 35573-439-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 35573-439-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 35573-439-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 35573-439-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 35573-439-02 ad56d346431e…cc804d4bbf1e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076868-001 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 A076868-002 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 A076868-003 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 A076868-004 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 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 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076868-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 2005-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076868-002 LOXAPINE SUCCINATE EQ 10MG BASE CAPSULE / ORAL AB 2005-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076868-003 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB 2005-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076868-004 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 2005-08-04 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35573-439-02 35573043902 100 CAPSULE in 1 BOTTLE (35573-439-02) 100 capsule 2021-05-01 0000-00-00 No No Current