Quetiapine Fumarate NDC 72865-264

NDC codes

FDA NDC Directory

Product NDC (as listed)72865-264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72865-0264Add 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
72865-264-01	72865026401	100 TABLET, FILM COATED in 1 BOTTLE (72865-264-01)Marketed from Feb 2, 2024
72865-264-10	72865026410	1000 TABLET, FILM COATED in 1 BOTTLE (72865-264-10)Marketed from Feb 2, 2024
72865-264-90	72865026490	90 TABLET, FILM COATED in 1 BOTTLE (72865-264-90)Marketed from Jul 22, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Fumarate
Generic name (nonproprietary): quetiapine fumarate
Active ingredients: Quetiapine fumarate — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: XLCare Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204316
Marketing start: Feb 2, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 72865-264_4dc52dc1-ab22-a157-e063-6394a90a9d23SPL ID 4dc52dc1-ab22-a157-e063-6394a90a9d23SPL set ID 070faf07-0ce7-4354-8643-9d222b72ecadRxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0372865269015, 0372865266014, 0372865267011, 0372865268605, 0372865264010, 0372865265017
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

N472865026401 followed by a unit qualifier and the quantity

Package 72865-0264-01. 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 24, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablets 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 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204316

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

FDA NDC Directory listings under ANDA 204316
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-267
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-265
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-266
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-268
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-269
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-768
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-766
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-767
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-769
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4701
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4705
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-764
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-765
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-764