Home NDC 0591-0369-77 Loxapine
Product NDC 0591-0369
Requested package NDC 0591-0369-77
11-digit product format 005910369
Labeler code 0591
Product ID 0591-0369_cae2db34-6be2-45cf-b9b5-9b929650eb4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loxapine
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA072204
Marketing category ANDA
Marketing start 1988-06-15
Substance LOXAPINE SUCCINATE
Active strength 5 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072204-001 LOXAPINE SUCCINATE LOXAPINE SUCCINATE EQ 5MG 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 A072204-001 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 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072204-001 LOXAPINE SUCCINATE EQ 5MG BASE CAPSULE / ORAL AB 1988-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072204-001 LOXAPINE SUCCINATE EQ 5MG 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOXAPINE SUCCINATE 5 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 0591-0369-01 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 LOXAPINE SUCCINATE ACTIVE INGREDIENT X59SG0MRYU LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 LOXAPINE ACTIVE MOIETY LER583670J LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 EDETATE CALCIUM DISODIUM INACTIVE INGREDIENT 25IH6R4SGF LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LOXAPINE CAPSULE [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-0369 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 0591-0369-77 00591036977 5883 CAPSULE in 1 CONTAINER (0591-0369-77) 5883 capsule 23-JAN-26 Current