Home NDC 35573-438-02 Loxapine
Product NDC 35573-438
Requested package NDC 35573-438-02
11-digit product format 355730438
Labeler code 35573
Product ID 35573-438_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 25 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 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 35573-438-02 35573043802 100 CAPSULE in 1 BOTTLE (35573-438-02) 100 capsule 2021-05-01 0000-00-00 No No Current