Prescription drug · ANDA

Fluoxetine (Fluoxetine hydrochloride) NDC 63187-069

Fluoxetine hydrochloride 20 mg/1 · Capsule · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-069Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0069Add 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
63187-069-30631870069306318700693030 CAPSULE in 1 BOTTLE (63187-069-30)Marketed from Apr 30, 2014
63187-069-60631870069606318700696060 CAPSULE in 1 BOTTLE (63187-069-60)Marketed from Apr 30, 2014
63187-069-90631870069906318700699090 CAPSULE in 1 BOTTLE (63187-069-90)Marketed from Apr 30, 2014

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 — 20 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
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 63187-069_27cdbe64-490e-4b1d-85da-f4a72a883098SPL ID 27cdbe64-490e-4b1d-85da-f4a72a883098SPL set ID 70e115cc-6e9b-4b96-a1a9-779ed51ad0a7RxCUI 310384, 310385UNII I9W7N6B1KJUPC 0363187069308, 0363187081300
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

N463187006930 followed by a unit qualifier and the quantity

Package 63187-0069-30. 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, USP are a selective serotonin reuptake inhibitor indicated for: • Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) • Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) • Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) Fluoxetine capsules, USP and olanzapine in combination for: • Acute treatment of Depressive Episodes Associated with Bipolar I Disorder (1.5) 1.1 Major Depressive Disorder Fluoxetine capsules,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-069

What is NDC 63187-069?
63187-069 is the product NDC for Fluoxetine (fluoxetine hydrochloride), Fluoxetine hydrochloride 20 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 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?
Proficient Rx LP, NDC labeler code 63187. 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 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 10 mg/1CapsuleOralBluePoint Laboratories68001-399
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralAmerican Health Packaging68002-105
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-031
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralBluePoint Laboratories68001-400
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralBluePoint Laboratories68001-401
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralNorthStar Rx LLC72603-489
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralNorthStar Rx LLC72603-488
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7951
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralNorthStar Rx LLC72603-490
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-0745
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-993
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7952
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-0417
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralCardinal Health 107, LLC55154-2638
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-1695
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralAurobindo Pharma Limited65862-193
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralAurobindo Pharma Limited65862-192
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralAurobindo Pharma Limited65862-194
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralNorthwind Health Company, LLC51655-981
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-6064

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