Prescription drug · ANDA

Fluoxetine (fluoxetine hydrochloride) NDC 83209-192

Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · Boswell Pharmacy Services LLC d/b/a BPS Wholesale

NDC codes

FDA NDC Directory
Product NDC (as listed)83209-192Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83209-0192Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
83209-192-108320901921010 CAPSULE in 1 BLISTER PACK (83209-192-10)Marketed from Aug 16, 2024
83209-192-158320901921515 CAPSULE in 1 BLISTER PACK (83209-192-15)Marketed from Aug 16, 2024
83209-192-308320901923030 CAPSULE in 1 BLISTER PACK (83209-192-30)Marketed from Aug 16, 2024
83209-192-608320901926060 CAPSULE in 1 BLISTER PACK (83209-192-60)Marketed from Aug 16, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Fluoxetine
Generic name (nonproprietary)
fluoxetine hydrochloride
Active ingredients
Fluoxetine hydrochloride — 10 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078619
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 83209-192_1fd02569-04f0-e34e-e063-6394a90a227bSPL ID 1fd02569-04f0-e34e-e063-6394a90a227bSPL set ID 1fd00b7f-df07-455f-e063-6394a90a1f10RxCUI 310384UNII I9W7N6B1KJ
Pharmacologic class
Serotonin Reuptake Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N483209019210 followed by a unit qualifier and the quantity

Package 83209-0192-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3) ] . Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4) ] . Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078619

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078619
ProductStrengthForm · routeLabelerProduct NDC
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-0417
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralNorthwind Health Company, LLC51655-981
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralNorthStar Rx LLC16714-721
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralAurobindo Pharma Limited65862-192
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralAurobindo Pharma Limited65862-193
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralNorthStar Rx LLC16714-720
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralQPharma Inc42708-182
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralAurobindo Pharma Limited65862-194
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-7914
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralNorthStar Rx LLC16714-722
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-721
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-7915
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-554
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralQPharma Inc42708-200
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-100
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-101
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-102
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7951
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7952
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-0745

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