Quetiapine NDC 0904-6804

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-6804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-6804Add 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
0904-6804-61	00904680461	100 BLISTER PACK in 1 CARTON (0904-6804-61) / 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 — 300 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Major Pharmaceuticals
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 0904-6804_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

N400904680461 followed by a unit qualifier and the quantity

Package 00904-6804-61. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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 200 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-614
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 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
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-6801
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 400 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-6805