Home NDC 70518-0416-1 Loxapine
Product NDC 70518-0416
Requested package NDC 70518-0416-1
11-digit product format 705180416
Labeler code 70518
Product ID 70518-0416_4b1a1631-5210-3d55-e063-6294a90a03dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loxapine
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA072062
Marketing category ANDA
Marketing start 2017-04-10
Substance LOXAPINE SUCCINATE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 12 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…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A072062-001 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072062-001 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 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072062-001 LOXAPINE SUCCINATE EQ 50MG BASE CAPSULE / ORAL AB 1988-06-15 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 Loxapine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOXAPINE SUCCINATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X59SG0MRYU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314075 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 70518-0416-0 Loxapine 30 in 1 BLISTER PACK CAPSULE 30 18 70518-0416-1 Loxapine 100 in 1 BOX CAPSULE 100 18 70518-0416-2 Loxapine 1 in 1 POUCH CAPSULE 1 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-0416 LOXAPINE CAPSULE [REMEDYREPACK INC.] 14 Current NDC, Legacy NDC, 3 package rows 20250502_ae8e299c-4003-4ccf-badc-fb665a997b20.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 70518-0416-1 70518041601 100 POUCH in 1 BOX (70518-0416-1) > 1 CAPSULE in 1 POUCH (70518-0416-2) 100 pouch 2019-05-02 0000-00-00 No No Current