What is NDC 63629-2198?

63629-2198 is the product NDC for fluoxetine hydrochloride, Fluoxetine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 hydrochloride?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

fluoxetine hydrochloride NDC 63629-2198

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-2198Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-2198Add 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 NDC	11-digit (billing)	Package	Copy
63629-2198-1	6362921980163629219801	100 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-2198-1)Marketed from Aug 22, 2016

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 hydrochloride
Generic name (nonproprietary): fluoxetine hydrochloride
Active ingredients: Fluoxetine hydrochloride — 10 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203836
Marketing start: Aug 22, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 63629-2198_79ce59f8-731b-48db-bf14-0ed6a64e8b72SPL ID 79ce59f8-731b-48db-bf14-0ed6a64e8b72SPL set ID d5a267cb-08bd-4530-a7a8-2bceddd828e5RxCUI 313990UNII 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

N463629219801 followed by a unit qualifier and the quantity

Package 63629-2198-01. 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 Jul 13, 2026. 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)

About NDC 63629-2198

What is NDC 63629-2198?: 63629-2198 is the product NDC for fluoxetine hydrochloride, Fluoxetine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: fluoxetine hydrochloride.
What is the active ingredient?: Fluoxetine hydrochloride.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. 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 hydrochloride?: 19 other product NDCs are listed under this name. See all fluoxetine hydrochloride 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 hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/5mL	For solutionOral	Upsher-Smith Laboratories, LLC	0832-6032	00832-6032-12
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 20 mg/5mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-600	70954-0600-10
Fluoxetine hydrochloride	Fluoxetine hydrochloride 60 mg/1	Tablet, Film coatedOral, Oral	NorthStar Rx LLC	16714-114	16714-0114-01
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 10 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-998	68180-0998-0168180-0998-06
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 20 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-999	68180-0999-0168180-0999-06
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 60 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-997	68180-0997-06
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 60 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	51672-5306	51672-5306-0251672-5306-06
Fluoxetine hydrochloride	Fluoxetine hydrochloride 60 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Inc.	43598-632	43598-0632-0143598-0632-30
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-242	46708-0242-3046708-0242-3146708-0242-91
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-243	46708-0243-3046708-0243-3146708-0243-91

All 20 fluoxetine hydrochloride NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
fluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	Tablet, CoatedOral	Par Health USA, LLC	49884-335
fluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	Tablet, CoatedOral	Par Health USA, LLC	49884-336
fluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	63629-2197
fluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	63629-2200
fluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	63629-8989
fluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	63629-8990
fluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	72162-1494
fluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	72162-1495