What is NDC 0904-6642?

0904-6642 is the product NDC for Quetiapine, Quetiapine fumarate 300 mg/1 tablet, film coated, 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 0904-6642 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-6642Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-6642Add 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
0904-6642-61	00904664261	100 BLISTER PACK in 1 CARTON (0904-6642-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 1, 2013

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 — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Major PharmaceuticalsNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
Marketing start: Mar 1, 2013
Listing expires: Dec 31, 2027
Identifiers: Product ID 0904-6642_493dac53-08c1-43d6-aeec-57b15b81609cSPL ID 493dac53-08c1-43d6-aeec-57b15b81609c
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

N400904664261 followed by a unit qualifier and the quantity

Package 00904-6642-61. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0904-6642

What is NDC 0904-6642?: 0904-6642 is the product NDC for Quetiapine, Quetiapine fumarate 300 mg/1 tablet, film coated, 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 400 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-602	68001-0602-06
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-599	68001-0599-06

All 87 Quetiapine NDCs

Other NDCs under ANDA 201504

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

FDA NDC Directory listings under ANDA 201504
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	TabletOral	AvPAK	50268-632
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	TabletOral	AvPAK	50268-630
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	TabletOral	AvPAK	50268-631
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	TabletOral	AvPAK	50268-634
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	TabletOral	AvPAK	50268-633
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	TabletOral	AvPAK	50268-635
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-514
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-512
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-513
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-522
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-516
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-518
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-519
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1519
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1562
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Proficient Rx LP	82804-094
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6638
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6639
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0186
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7813

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