FDA.reportPublic FDA data

FLUOXETINE

Product NDC
61919-100
11-digit product format
619190100
Labeler code
61919
Product ID
61919-100_f20208a0-3357-d06a-e053-2995a90aa04d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA076001
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-100-302025-01-30C16284748780-12cef2736-928f-d83d-e063-dadaa90ab31fFLUOXETINE
61919-100-902025-01-30C16284748780-12cef2736-928f-d83d-e063-dadaa90ab31fFLUOXETINE
61919-100-602023-01-30C16284748780-1f386c64a-13ea-0266-e053-dadaa90a7c1aFLUOXETINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-100-30FLUOXETINE30 in 1 BOTTLECAPSULE3012
61919-100-90FLUOXETINE90 in 1 BOTTLECAPSULE9012
61919-100-60FLUOXETINE60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-100-30EA - Each61919-10016ec69bd-c3b7-492e-baae-9448e36d999612014-05-02
61919-100-60EA - Each61919-100c4ae7cf1-7b33-4831-999b-13292584b2ae12014-05-02
61919-100-90EA - Each61919-100efa3ac8b-df8d-4142-ad06-bac01cfed43112015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [DIRECT RX]4
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [DIRECT RX]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUOXETINE CAPSULE [DIRECT RX]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE CAPSULE [DIRECT RX]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [DIRECT RX]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [DIRECT RX]4
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [DIRECT RX]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [DIRECT RX]4
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [DIRECT RX]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-100FLUOXETINE CAPSULE [DIRECT_RX]12Legacy NDC, 2 package rows20230412_ea1c989b-3395-4e68-a300-f0f042969c4f.zip
61919-100FLUOXETINE CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190810_8fa0adab-70ae-484b-e053-2a95a90a6552.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNea1c989b-3395-4e68-a300-f0f042969c4f12
310385fluoxetine 20 MG Oral CapsuleSCDea1c989b-3395-4e68-a300-f0f042969c4f12
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYea1c989b-3395-4e68-a300-f0f042969c4f12
310385FLUoxetine 20 MG Oral CapsulePSN8fa0adab-70ae-484b-e053-2a95a90a65521
310385fluoxetine 20 MG Oral CapsuleSCD8fa0adab-70ae-484b-e053-2a95a90a65521
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY8fa0adab-70ae-484b-e053-2a95a90a65521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-100-306191901003030 CAPSULE in 1 BOTTLE (61919-100-30) 30 capsule2019-09-160000-00-00NoNoCurrent
61919-100-606191901006060 CAPSULE in 1 BOTTLE (61919-100-60) 60 capsule2019-08-080000-00-00NoNoCurrent
61919-100-906191901009090 CAPSULE in 1 BOTTLE (61919-100-90) 90 capsule2019-09-160000-00-00NoNoCurrent