Prescription drug · ANDA

Fluoxetine (Fluoxetine hydrochloride) NDC 50090-6065

Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6065Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6065Add 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
50090-6065-05009060650030 CAPSULE in 1 BOTTLE (50090-6065-0)Marketed from Sep 9, 2022
50090-6065-25009060650290 CAPSULE in 1 BOTTLE (50090-6065-2)Marketed from Sep 9, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler
A-S Medication SolutionsNDC labeler code 50090
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 50090-6065_60f6e474-597b-4231-b421-e4ef1c193f47SPL ID 60f6e474-597b-4231-b421-e4ef1c193f47SPL set ID 1226a67f-ec09-42f6-9d1b-9ddd862ea0a0RxCUI 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

N450090606500 followed by a unit qualifier and the quantity

Package 50090-6065-00. 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)

About NDC 50090-6065

What is NDC 50090-6065?
50090-6065 is the product NDC for Fluoxetine (fluoxetine hydrochloride), Fluoxetine hydrochloride 10 mg/1 capsule, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fluoxetine (Fluoxetine Hydrochloride).
What is the active ingredient?
Fluoxetine hydrochloride.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluoxetine?
193 other product NDCs are listed under this name. See all Fluoxetine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluoxetine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralAmerican Health Packaging68002-10568002-0105-01
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-03187441-0031-01
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralCoupler LLC67046-055267046-0552-03
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-208367046-2083-03
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralREMEDYREPACK INC.70518-461170518-4611-00
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralCoupler LLC67046-167067046-1670-03
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralNorthwind Health Company, LLC82868-10582868-0105-3082868-0105-90
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-457670518-4576-00
FluoxetineFluoxetine hydrochloride 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited84386-10484386-0104-0184386-0104-30
FluoxetineFluoxetine hydrochloride 60 mg/1Tablet, Film coatedOralAurobindo Pharma Limited84386-10684386-0106-30

All 194 Fluoxetine NDCs

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/1CapsuleOralNorthwind Health Company, LLC51655-100
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-0745
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralAurobindo Pharma Limited59651-900
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralAurobindo Pharma Limited59651-898
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralAurobindo Pharma Limited59651-899
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-4576
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8612
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-6064
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralAmerican Health Packaging60687-659
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralNorthwind Health Company, LLC82868-105
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralBryant Ranch Prepack71335-1145
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralCouplerLLC67046-1580
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-993
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralMajor Pharmaceuticals0904-7345
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralNorthStar Rx LLC72603-488
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralNorthStar Rx LLC72603-489
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralNorthStar Rx LLC72603-490
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8183
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-031
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralREMEDYREPACK INC.70518-4611

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