FDA.reportPublic FDA data

Amoxapine

Product NDC
0591-5713
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

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXAPINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR63VQ857OT
Rxcui197363, 197364, 197365, 197366

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
0591-5713-01Amoxapine100 in 1 BOTTLE, PLASTICTABLET10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5713-01EA - Each0591-57138df22d9a-e3ea-4f91-bac5-7b8af58e788412012-07-24

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
0591-5713AMOXAPINE TABLET [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20241213_a16297df-3158-48db-85e5-5cd506885556.zip

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 endSampleExclude flagStatus
0591-5713-0100591571301100 TABLET in 1 BOTTLE, PLASTIC (0591-5713-01) 100 tablet1992-08-280000-00-00NoNoCurrent