Prescription drug · ANDA

Fluoxetine (fluoxetine hydrochloride) NDC 63187-081

Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-081Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0081Add 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
63187-081-306318700813030 CAPSULE in 1 BOTTLE (63187-081-30)Marketed from Apr 30, 2014
63187-081-606318700816060 CAPSULE in 1 BOTTLE (63187-081-60)Marketed from Apr 30, 2014
63187-081-906318700819090 CAPSULE in 1 BOTTLE (63187-081-90)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 — 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 63187-081_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

N463187008130 followed by a unit qualifier and the quantity

Package 63187-0081-30. 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)

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 10 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-192
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

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