Home NDC 0591-5713-01 Amoxapine
Product NDC 0591-5713
Requested package NDC 0591-5713-01
11-digit product format 005915713
Labeler code 0591
Product ID 0591-5713_1245e142-4acf-4201-9aa9-5ace39ddc01f
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 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
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
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 0591-5713-01 00591571301 100 TABLET in 1 BOTTLE, PLASTIC (0591-5713-01) 100 tablet 1992-08-28 0000-00-00 No No Current