FDA.reportPublic FDA data

Fluoxetine

Product NDC
42543-727
11-digit product format
425430727
Labeler code
42543
Product ID
42543-727_f1764ef9-4324-4e97-a72c-d54bb09245ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Vensun Pharmaceuticals, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384, 310385, 313989

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
42543-727-01Fluoxetine100 in 1 BOTTLECAPSULE1009
42543-727-05Fluoxetine500 in 1 BOTTLECAPSULE5009
42543-727-30Fluoxetine30 in 1 BOTTLECAPSULE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-727-01EA - Each42543-727935dc4b2-30bf-44be-8f30-1f3cf3bf3a4012015-12-02
42543-727-05EA - Each42543-7278c1d0fba-994a-4c2e-afa7-54889674aa2712015-12-02
42543-727-30EA - Each42543-72770eb4a16-0f71-4c5b-9258-15e78ce1ddff12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-727FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 3 package rows20171031_b4f37ef1-8f5e-4318-90f1-2d8f8afb669c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
310385FLUoxetine 20 MG Oral CapsulePSNb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
313989FLUoxetine 40 MG Oral CapsulePSNb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
310384fluoxetine 10 MG Oral CapsuleSCDb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
310385fluoxetine 20 MG Oral CapsuleSCDb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
313989fluoxetine 40 MG Oral CapsuleSCDb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYb4f37ef1-8f5e-4318-90f1-2d8f8afb669c9
313989FLUoxetine 40 MG Oral CapsulePSN581fee7f-2c89-4815-8af7-9ee4ee4226f85
313989fluoxetine 40 MG Oral CapsuleSCD581fee7f-2c89-4815-8af7-9ee4ee4226f85
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY581fee7f-2c89-4815-8af7-9ee4ee4226f85
310384FLUoxetine 10 MG Oral CapsulePSN02283de9-6087-45f7-a9ce-3b082ce860de3
310385FLUoxetine 20 MG Oral CapsulePSN02283de9-6087-45f7-a9ce-3b082ce860de3
313989FLUoxetine 40 MG Oral CapsulePSNa6457d6e-5586-40e9-883d-352ee0527d803
313989FLUoxetine 40 MG Oral CapsulePSN02283de9-6087-45f7-a9ce-3b082ce860de3
310384fluoxetine 10 MG Oral CapsuleSCD02283de9-6087-45f7-a9ce-3b082ce860de3
310385fluoxetine 20 MG Oral CapsuleSCD02283de9-6087-45f7-a9ce-3b082ce860de3
313989fluoxetine 40 MG Oral CapsuleSCDa6457d6e-5586-40e9-883d-352ee0527d803
313989fluoxetine 40 MG Oral CapsuleSCD02283de9-6087-45f7-a9ce-3b082ce860de3
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY02283de9-6087-45f7-a9ce-3b082ce860de3
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY02283de9-6087-45f7-a9ce-3b082ce860de3
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYa6457d6e-5586-40e9-883d-352ee0527d803
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY02283de9-6087-45f7-a9ce-3b082ce860de3
313989FLUoxetine 40 MG Oral CapsulePSN8fa00971-6d50-2d88-e053-2a95a90aed6a1
313989FLUoxetine 40 MG Oral CapsulePSN71665258-ad45-4dad-e053-2995a90aedcc1
313989fluoxetine 40 MG Oral CapsuleSCD71665258-ad45-4dad-e053-2995a90aedcc1
313989fluoxetine 40 MG Oral CapsuleSCD8fa00971-6d50-2d88-e053-2a95a90aed6a1
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY8fa00971-6d50-2d88-e053-2a95a90aed6a1
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY71665258-ad45-4dad-e053-2995a90aedcc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-727-0142543072701100 CAPSULE in 1 BOTTLE (42543-727-01) 100 capsule2015-03-160000-00-00NoNoCurrent
42543-727-0542543072705500 CAPSULE in 1 BOTTLE (42543-727-05) 500 capsule2015-03-160000-00-00NoNoCurrent
42543-727-304254307273030 CAPSULE in 1 BOTTLE (42543-727-30) 30 capsule2015-03-160000-00-00NoNoCurrent