FDA.reportPublic FDA data

Fluoxetine

Product NDC
43063-570
11-digit product format
430630570
Labeler code
43063
Product ID
43063-570_509b7cc3-bb32-68ff-e063-6294a90a2344
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
Marketing end
2028-02-29
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-570-21Fluoxetine21 in 1 BOTTLE, PLASTICCAPSULE2136
43063-570-28Fluoxetine28 in 1 BOTTLE, PLASTICCAPSULE2836
43063-570-30Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE3036
43063-570-90Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE9036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-570-21EA - Each43063-5707be587c8-777c-442e-939a-88ea086d40c912017-03-06
43063-570-28EA - Each43063-570a616901b-5c1e-4e33-919a-dfbd3b420b0412016-03-04
43063-570-30EA - Each43063-57003036ce1-4480-4297-b9f1-c41fb2ef840f12015-05-05
43063-570-90EA - Each43063-570b20c2f30-fdd6-4a4a-811f-1ee3578244ca12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-570FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]34Current NDC, Legacy NDC, 4 package rows20240815_7d7a196b-91de-4753-8bb6-c6d5c668952d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN7d7a196b-91de-4753-8bb6-c6d5c668952d36
310384fluoxetine 10 MG Oral CapsuleSCD7d7a196b-91de-4753-8bb6-c6d5c668952d36
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY7d7a196b-91de-4753-8bb6-c6d5c668952d36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-570-214306305702121 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-21) 21 capsule2017-02-012028-02-29NoNoCurrent
43063-570-284306305702828 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-28) 28 capsule2016-01-272028-02-29NoNoCurrent
43063-570-304306305703030 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-30) 30 capsule2015-04-142028-02-29NoNoCurrent
43063-570-904306305709090 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-90) 90 capsule2015-04-142028-02-29NoNoCurrent