Amoxapine

Product NDC
0591-5716
Requested package NDC
0591-5716-77
11-digit product format
005915716
Labeler code
0591
Product ID
0591-5716_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
150 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage0591-57160591-5716-77UNFINISHEDActive or certified unfinished drug listing2026-10-05

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 dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072691-001AMOXAPINEAMOXAPINE150MGTABLET / ORALABRS1992-08-28
A072691-002AMOXAPINEAMOXAPINE25MGTABLET / ORALAB1992-08-28
A072691-003AMOXAPINEAMOXAPINE50MGTABLET / ORALAB1992-08-28
A072691-004AMOXAPINEAMOXAPINE100MGTABLET / ORALAB1992-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A072691-001AB
A072691-002AB
A072691-003AB
A072691-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-2884e616aacf4f…
2026-09-14 22:38:342026-08A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-2884e616aacf4f…
2026-09-14 22:38:342026-08A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-2884e616aacf4f…
2026-09-14 22:38:342026-08A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-2884e616aacf4f…
2026-08-18 06:07:402026-07A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-001AMOXAPINE150MGTABLET / ORALABRS1992-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-002AMOXAPINE25MGTABLET / ORALAB1992-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-003AMOXAPINE50MGTABLET / ORALAB1992-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-004AMOXAPINE100MGTABLET / ORALAB1992-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072691-001AMOXAPINE150MGTABLET / ORALRS1992-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072691-002AMOXAPINE25MGTABLET / ORAL1992-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072691-003AMOXAPINE50MGTABLET / ORAL1992-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072691-004AMOXAPINE100MGTABLET / ORAL1992-08-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A072691-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A072691-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A072691-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A072691-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A072691-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A072691-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A072691-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A072691-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072691-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072691-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072691-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072691-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072691-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072691-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072691-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072691-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072691-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072691-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072691-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072691-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072691-004AB12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072691-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072691-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072691-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072691-004AB1a50c72e98297…

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
IngredientStrength
AMOXAPINE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R63VQ857OTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197363Internal RxNorm lookup
197364Internal RxNorm lookup
197365Internal RxNorm lookup
197366Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a16297df-3158-48db-85e5-5cd506885556Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e68f88c-d1e3-bbd0-bea1-34dcc08a53cbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5716-30Amoxapine30 in 1 BOTTLE, PLASTICTABLET3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5716-30EA - Each0591-5716f85f60a5-73cd-401f-85f7-b48d302aca5c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXAPINEACTIVE INGREDIENTR63VQ857OTAMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12
AMOXAPINEACTIVE MOIETYR63VQ857OTAMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAMOXAPINE TABLET [ACTAVIS PHARMA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5716AMOXAPINE TABLET [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20241213_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxapineAMOXAPINEActavis Pharma, Inc.a16297df-3158-48db-85e5-5cd5068855562024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072691
application number: ANDA072691
ndc (product): 0591-5716

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197363amoxapine 100 MG Oral TabletPSNa16297df-3158-48db-85e5-5cd50688555620
197364amoxapine 150 MG Oral TabletPSNa16297df-3158-48db-85e5-5cd50688555620
197365amoxapine 25 MG Oral TabletPSNa16297df-3158-48db-85e5-5cd50688555620
197366amoxapine 50 MG Oral TabletPSNa16297df-3158-48db-85e5-5cd50688555620
197363amoxapine 100 MG Oral TabletSCDa16297df-3158-48db-85e5-5cd50688555620
197364amoxapine 150 MG Oral TabletSCDa16297df-3158-48db-85e5-5cd50688555620
197365amoxapine 25 MG Oral TabletSCDa16297df-3158-48db-85e5-5cd50688555620
197366amoxapine 50 MG Oral TabletSCDa16297df-3158-48db-85e5-5cd50688555620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endStatus
0591-5716-770059157167734284 TABLET in 1 CONTAINER (0591-5716-77)34284 tablet31-JUL-2430-JUN-27Historical