Home NDC 0591-5713-77 Amoxapine
Product NDC 0591-5713
Requested package NDC 0591-5713-77
11-digit product format 005915713
Labeler code 0591
Product ID 0591-5713_40931661-1155-4850-baaa-227f066ed616
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxapine
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA072691
Marketing category ANDA
Marketing start 1992-08-28
Substance AMOXAPINE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
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 · 11 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A072691-001 AMOXAPINE AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 A072691-002 AMOXAPINE AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 A072691-003 AMOXAPINE AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 A072691-004 AMOXAPINE AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28
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 · 172 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 2026-09-14 22:38:34 2026-08 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072691-001 AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072691-002 AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072691-003 AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072691-004 AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amoxapine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXAPINE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R63VQ857OT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197363 Internal RxNorm lookup 197364 Internal RxNorm lookup 197365 Internal RxNorm lookup 197366 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 0591-5713-01 Amoxapine 100 in 1 BOTTLE, PLASTIC TABLET 100 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMOXAPINE ACTIVE INGREDIENT R63VQ857OT AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12 AMOXAPINE ACTIVE MOIETY R63VQ857OT AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5713 AMOXAPINE TABLET [ACTAVIS PHARMA, INC.] 19 Current NDC, Legacy NDC, 1 package rows 20241213_a16297df-3158-48db-85e5-5cd506885556.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 Status 0591-5713-77 00591571377 92304 TABLET in 1 CONTAINER (0591-5713-77) 92304 tablet 31-JUL-24 30-JUN-27 Historical