What is NDC 71335-1353?

71335-1353 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 50 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 71335. 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 71335-1353

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1353Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1353Add 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
71335-1353-1	7133513530171335135301	30 TABLET, FILM COATED in 1 BOTTLE (71335-1353-1)Marketed from Nov 5, 2019
71335-1353-2	7133513530271335135302	60 TABLET, FILM COATED in 1 BOTTLE (71335-1353-2)Marketed from Oct 3, 2019
71335-1353-3	7133513530371335135303	90 TABLET, FILM COATED in 1 BOTTLE (71335-1353-3)Marketed from Sep 26, 2019
71335-1353-4	7133513530471335135304	25 TABLET, FILM COATED in 1 BOTTLE (71335-1353-4)Marketed from May 20, 2024
71335-1353-5	7133513530571335135305	120 TABLET, FILM COATED in 1 BOTTLE (71335-1353-5)Marketed from May 20, 2024

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 — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202674
Marketing start: Jul 1, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 71335-1353_a2688211-bc1c-463d-90e5-47476a140965SPL ID a2688211-bc1c-463d-90e5-47476a140965SPL set ID 1618989e-2e6b-49ff-81b5-cf80d1dcfab4RxCUI 616487UNII 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

N471335135301 followed by a unit qualifier and the quantity

Package 71335-1353-01. 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 Mar 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablets, USP are 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 tablets, USP are indicated for the treatment of schizophrenia. The efficacy of Quetiapine tablets, USP in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of Quetiapine tablets, USP 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 tablets, USP are indicated fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1353

What is NDC 71335-1353?: 71335-1353 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 50 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 71335. 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 202674

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

FDA NDC Directory listings under ANDA 202674
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8470
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8471
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8472
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8473
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8474
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8568
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-147
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-148
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-149
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-150
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-151
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-152
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3377
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3983
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1649
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3931
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2175
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3747
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0184