NDC codes

FDA NDC Directory
Product NDC (as listed)60687-845Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0845Add 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
60687-845-7760687084577606870845774 TRAY in 1 CASE (60687-845-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40)Marketed from Dec 4, 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
Active ingredients
Fluoxetine hydrochloride — 20 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
American Health PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079209
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 60687-845_31f54f70-b632-cb9e-e063-6394a90a329fSPL ID 31f54f70-b632-cb9e-e063-6394a90a329fSPL set ID 3276a2a4-61c7-4de6-b519-3aa8b62da88fRxCUI 310386UNII 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

N460687084577 followed by a unit qualifier and the quantity

Package 60687-0845-77. 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 oral solution is 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 monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60687-845

What is NDC 60687-845?
60687-845 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/5mL solution, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fluoxetine.
What is the active ingredient?
Fluoxetine hydrochloride.
Who is the labeler?
American Health Packaging, NDC labeler code 60687. 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?
200 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 hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralCoupler LLC67046-040567046-0405-03
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-169567046-1695-03
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

All 201 Fluoxetine NDCs

Other NDCs under ANDA 079209

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

FDA NDC Directory listings under ANDA 079209
ProductStrengthForm · routeLabelerProduct NDC
FluoxetineFluoxetine hydrochloride 20 mg/5mLSolutionOralAurobindo Pharma Limited65862-306

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