Prescription drug · ANDA

fluoxetine hydrochloride NDC 49884-335

Fluoxetine hydrochloride 10 mg/1 · Tablet, Coated · Oral · Par Health USA, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)49884-335Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49884-0335Add 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
49884-335-0149884033501100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01)Marketed from Aug 22, 2016
49884-335-114988403351130 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-11)Marketed from Aug 22, 2016

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 hydrochloride
Generic name (nonproprietary)
fluoxetine hydrochloride
Active ingredients
Fluoxetine hydrochloride — 10 mg/1
Dosage form
Tablet, Coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203836
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 49884-335_caca8641-502e-40dd-a219-2eb49188413fSPL ID caca8641-502e-40dd-a219-2eb49188413fSPL set ID 53ac797d-8792-4a8c-9708-d1de3d377e8fRxCUI 248642, 313990UNII I9W7N6B1KJUPC 0349884335014, 0349884336011, 0349884335113, 0349884335106, 0349884336103, 0349884336110
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

N449884033501 followed by a unit qualifier and the quantity

Package 49884-0335-01. 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 is 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 adults 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) Indication Adult Pediatric MDD (2.1) 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD (2.2) 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa (2.3) 60 mg/day in am Panic Disor…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203836

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

FDA NDC Directory listings under ANDA 203836
ProductStrengthForm · routeLabelerProduct NDC
fluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1Tablet, CoatedOralBryant Ranch Prepack63629-2197
fluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1Tablet, CoatedOralBryant Ranch Prepack63629-2198
fluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1Tablet, CoatedOralBryant Ranch Prepack63629-2200
fluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1Tablet, CoatedOralPar Health USA, LLC49884-336
fluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1Tablet, CoatedOralBryant Ranch Prepack63629-8989
fluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1Tablet, CoatedOralBryant Ranch Prepack63629-8990
fluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1Tablet, CoatedOralBryant Ranch Prepack72162-1494
fluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1Tablet, CoatedOralBryant Ranch Prepack72162-1495

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fluoxetine hydrochloride NDC 49884-335 | Med-Code