Fluoxetine

Product NDC
42291-397
11-digit product format
422910397
Labeler code
42291
Product ID
42291-397_d57b14b4-16dc-2b6a-e053-2a95a90a3bd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA076001
Marketing category
ANDA
Marketing start
2017-08-14
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
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-397-01EA - Each42291-397d1802296-df51-4903-895d-7e5ecf70145812017-10-13
42291-397-10EA - Each42291-397db91f8d8-b5f6-4b2e-a826-94002575762212017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-397FLUOXETINE CAPSULE [AVKARE]7Legacy NDC20240110_847edbf4-f40e-4493-ba74-aac21225eb99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN9958c749-391b-409f-ab34-206806eac9652
310385FLUoxetine 20 MG Oral CapsulePSNa298f270-67c9-42cc-9089-6a1e3c3149b32
310385fluoxetine 20 MG Oral CapsuleSCD9958c749-391b-409f-ab34-206806eac9652
310385fluoxetine 20 MG Oral CapsuleSCDa298f270-67c9-42cc-9089-6a1e3c3149b32
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY9958c749-391b-409f-ab34-206806eac9652
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa298f270-67c9-42cc-9089-6a1e3c3149b32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-397-0142291039701100 CAPSULE in 1 BOTTLE (42291-397-01) 100 capsule2017-08-140000-00-00NoNoCurrent
42291-397-10422910397101000 CAPSULE in 1 BOTTLE (42291-397-10) 1000 capsule2017-08-140000-00-00NoNoCurrent