What is NDC 71335-2278?

71335-2278 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 300 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 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 71335-2278 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2278Add 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
71335-2278-1	71335227801	30 TABLET in 1 BOTTLE (71335-2278-1)Marketed from Nov 9, 2023
71335-2278-2	71335227802	60 TABLET in 1 BOTTLE (71335-2278-2)Marketed from Jan 31, 2025
71335-2278-3	71335227803	28 TABLET in 1 BOTTLE (71335-2278-3)Marketed from Jan 31, 2025
71335-2278-4	71335227804	90 TABLET in 1 BOTTLE (71335-2278-4)Marketed from Jan 31, 2025

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 — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
Marketing start: Mar 27, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 71335-2278_9f565396-87ee-4749-8683-b1f56d3c0c4fSPL ID 9f565396-87ee-4749-8683-b1f56d3c0c4fSPL set ID 94a81681-381e-4b3b-89ac-e86dcbe7f890RxCUI 312745UNII 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

N471335227801 followed by a unit qualifier and the quantity

Package 71335-2278-01. 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 15, 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 tablets are 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 tablets are indicated for the acute treatment of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2278

What is NDC 71335-2278?: 71335-2278 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 300 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 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 fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-073	87441-0073-01
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-074	87441-0074-01
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 201109

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

FDA NDC Directory listings under ANDA 201109
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine fumaratequetiapine	Quetiapine fumarate 400 mg/1	TabletOral	American Health Packaging	60687-382
Quetiapine fumaratequetiapine	Quetiapine fumarate 25 mg/1	TabletOral	American Health Packaging	60687-327
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0413
Quetiapine fumaratequetiapine	Quetiapine fumarate 50 mg/1	TabletOral	American Health Packaging	60687-338
Quetiapine fumaratequetiapine	Quetiapine fumarate 100 mg/1	TabletOral	American Health Packaging	60687-349
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	American Health Packaging	60687-360
Quetiapine fumaratequetiapine	Quetiapine fumarate 300 mg/1	TabletOral	American Health Packaging	60687-371
Quetiapine fumaratequetiapine	Quetiapine fumarate 25 mg/1	TabletOral	Coupler LLC	67046-1116
Quetiapine fumarate	Quetiapine fumarate 400 mg/1	TabletOral	REMEDYREPACK INC.	70518-2752
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-448
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-445
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-446
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-447
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-096
Quetiapine fumarate	Quetiapine fumarate 300 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-449
Quetiapine fumarate	Quetiapine fumarate 400 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-450
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-095
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8746
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-097
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-098

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