Home NDC 64850-891 Loxapine
Product NDC 64850-891
11-digit product format 648500891
Labeler code 64850
Product ID 64850-891_538b7d03-c464-465d-b690-9701c14cf580
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loxapine
Dosage form CAPSULE
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA076868
Marketing category ANDA
Marketing start 2020-01-27
Substance LOXAPINE SUCCINATE
Active strength 10 mg/1
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Loxapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOXAPINE SUCCINATE 10 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311385 Internal RxNorm lookup 311386 Internal RxNorm lookup 314075 Internal RxNorm lookup 314078 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 64850-891-01 Loxapine 100 in 1 BOTTLE CAPSULE 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-891 LOXAPINE CAPSULE [ELITE LABORATORIES, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250303_a0cc7bb6-075f-47d1-8935-eb77a29d8c45.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 64850-891-01 64850089101 100 CAPSULE in 1 BOTTLE (64850-891-01) 100 capsule 2020-01-27 0000-00-00 No No Current