Home NDC 0591-0371 Loxapine
Product NDC 0591-0371
11-digit product format 005910371
Labeler code 0591
Product ID 0591-0371_cae2db34-6be2-45cf-b9b5-9b929650eb4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loxapine
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA072206
Marketing category ANDA
Marketing start 1988-06-15
Substance LOXAPINE SUCCINATE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-0371 UNFINISHED Active or certified unfinished drug listing 2026-08-10 unfinished package package 0591-0371 0591-0371-00 UNFINISHED Active or certified unfinished drug listing 2026-08-10 unfinished package package 0591-0371 0591-0371-77 UNFINISHED Active or certified unfinished drug listing 2026-08-10
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 · 53 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A072206-001 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 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 A072206-001 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 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 1988-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072206-001 LOXAPINE SUCCINATE EQ 25MG BASE CAPSULE / ORAL AB RS 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOXAPINE SUCCINATE 25 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 0591-0371-01 Loxapine 100 in 1 BOTTLE, PLASTIC CAPSULE 100 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOXAPINE SUCCINATE ACTIVE INGREDIENT X59SG0MRYU LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 LOXAPINE ACTIVE MOIETY LER583670J LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 EDETATE CALCIUM DISODIUM INACTIVE INGREDIENT 25IH6R4SGF LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 GELATIN INACTIVE INGREDIENT 2G86QN327L LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOXAPINE CAPSULE [WATSON LABORATORIES, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-0371 LOXAPINE CAPSULE [ACTAVIS PHARMA, INC.] 19 Current NDC, Legacy NDC, 1 package rows 20250326_a6107bb1-3e23-4c5d-bbf4-5e29deff6728.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 0591-0371-00 00591037100 42400 CAPSULE in 1 BAG (0591-0371-00) 42400 capsule 15-JUN-88 Current 0591-0371-01 00591037101 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0371-01) 100 capsule 1988-06-15 0000-00-00 No No Current 0591-0371-77 00591037177 21240 CAPSULE in 1 CONTAINER (0591-0371-77) 21240 capsule 22-AUG-24 Current