What is NDC 0904-6801?

0904-6801 is the product NDC for Quetiapine, Quetiapine fumarate 50 mg/1 tablet, film coated, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Major Pharmaceuticals, NDC labeler code 0904. 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?

86 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Quetiapine NDC 0904-6801 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-6801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-6801Add 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
0904-6801-61	0090468016100904680161	100 BLISTER PACK in 1 CARTON (0904-6801-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 22, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Quetiapine
Generic name (nonproprietary): quetiapine
Active ingredients: Quetiapine fumarate — 50 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Major PharmaceuticalsNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204203
Marketing start: Aug 22, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 0904-6801_19c4edd2-4fc7-40b5-8204-178a933b7be4SPL ID 19c4edd2-4fc7-40b5-8204-178a933b7be4SPL set ID b02324b1-e7f0-4cbc-8778-5f7c4a5d194aRxCUI 721791, 721794, 721796, 853201, 895670UNII 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

N400904680161 followed by a unit qualifier and the quantity

Package 00904-6801-61. 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 16, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder, manic or mixed episodes ( 1.2 ) • Bipolar disorder, depressive episodes ( 1.2 ) • Major depressive disorder, adjunctive therapy with antidepressants ( 1.3 ) 1.1 Schizophrenia Quetiapine extended-release tablet USP is indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablet USP in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6801

What is NDC 0904-6801?: 0904-6801 is the product NDC for Quetiapine, Quetiapine fumarate 50 mg/1 tablet, film coated, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Quetiapine.
What is the active ingredient?: Quetiapine fumarate.
Who is the labeler?: Major Pharmaceuticals, NDC labeler code 0904. 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?: 86 other product NDCs are listed under this name. See all Quetiapine 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4700	70518-4700-00
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4699	70518-4699-00
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0487	67046-0487-03
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1623	67046-1623-03
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4451	70518-4451-00
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4437	70518-4437-00
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4430	70518-4430-0070518-4430-01
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-598	68001-0598-06
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-599	68001-0599-06
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-600	68001-0600-06

All 87 Quetiapine NDCs

Other NDCs under ANDA 204203

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

FDA NDC Directory listings under ANDA 204203
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-6802
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-6803
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-6804
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-6805
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-612
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-613
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-614
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-615
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-616