FLUOXETINE HYDROCHLORIDE

Product NDC
61919-099
11-digit product format
619190099
Labeler code
61919
Product ID
61919-099_3f7dc4b0-ee3b-4c96-bbf3-249c304f3af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075049
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-099-302020-01-31C16284748780-19d75b9d0-227b-f424-e053-dadaa90a57ceFLUOXETINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-099-30FLUOXETINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-099-30EA - Each61919-099fbf52c06-f508-4050-ae94-0d717ac7f7ba12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-099FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX]2Legacy NDC, 1 package rows20151103_79dc6790-d679-4e6e-9e3f-7de8e88d4837.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN79dc6790-d679-4e6e-9e3f-7de8e88d48372
310384fluoxetine 10 MG Oral CapsuleSCD79dc6790-d679-4e6e-9e3f-7de8e88d48372
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY79dc6790-d679-4e6e-9e3f-7de8e88d48372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-099-306191900993030 in 1 BOTTLEHistorical