What is NDC 63629-4964?

63629-4964 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, 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 Quetiapine Fumarate?

214 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Quetiapine Fumarate NDC 63629-4964

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-4964Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-4964Add 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
63629-4964-1	6362949640163629496401	30 TABLET, FILM COATED in 1 BOTTLE (63629-4964-1)Marketed from Mar 29, 2013
63629-4964-2	6362949640263629496402	100 TABLET, FILM COATED in 1 BOTTLE (63629-4964-2)Marketed from Apr 25, 2013
63629-4964-3	6362949640363629496403	120 TABLET, FILM COATED in 1 BOTTLE (63629-4964-3)Marketed from Aug 8, 2024
63629-4964-4	6362949640463629496404	90 TABLET, FILM COATED in 1 BOTTLE (63629-4964-4)Marketed from Dec 15, 2016
63629-4964-5	6362949640563629496405	60 TABLET, FILM COATED in 1 BOTTLE (63629-4964-5)Marketed from Sep 21, 2017

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): Quetiapine Fumarate
Generic name (nonproprietary): quetiapine fumarate
Active ingredients: Quetiapine fumarate — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202152
Marketing start: Mar 28, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 63629-4964_a11c9785-4dd7-4064-a8b1-171c1677ed71SPL ID a11c9785-4dd7-4064-a8b1-171c1677ed71SPL set ID 4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494fRxCUI 317174UNII 2S3PL1B6UJ
Pharmacologic class: Atypical Antipsychotic

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

N463629496401 followed by a unit qualifier and the quantity

Package 63629-4964-01. 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 Apr 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder Quetiapine tablet is indicated for the acute treatment of manic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-4964

What is NDC 63629-4964?: 63629-4964 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Quetiapine Fumarate.
What is the active ingredient?: Quetiapine fumarate.
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 Quetiapine Fumarate?: 214 other product NDCs are listed under this name. See all Quetiapine Fumarate 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 Quetiapine Fumarate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4701	70518-4701-00
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4705	70518-4705-00
Quetiapine fumaratequetiapine	Quetiapine fumarate 25 mg/1	TabletOral	Coupler LLC	67046-1116	67046-1116-03
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-074	87441-0074-01
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-073	87441-0073-01
Quetiapine fumaratequetiapine	Quetiapine fumarate 50 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-071	87441-0071-01
Quetiapine fumaratequetiapine	Quetiapine fumarate 100 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-072	87441-0072-01
Quetiapine fumaratequetiapine	Quetiapine fumarate 300 mg/1	TabletOral	Coupler LLC	67046-0638	67046-0638-03
Quetiapine fumaratequetiapine	Quetiapine fumarate 100 mg/1	TabletOral	Coupler LLC	67046-0636	67046-0636-03
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	Coupler LLC	67046-0637	67046-0637-03

All 215 Quetiapine Fumarate NDCs

Other NDCs under ANDA 202152

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

FDA NDC Directory listings under ANDA 202152
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-452
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-7116
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-219
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-269
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-4776
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-4841
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-145
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-148
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-146
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-147
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-149
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-150
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-401