What is NDC 50268-634?

50268-634 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 300 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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?

208 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 50268-634 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-634Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0634Add 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
50268-634-15	50268063415	50 BLISTER PACK in 1 BOX (50268-634-15) / 1 TABLET in 1 BLISTER PACK (50268-634-11)Marketed from May 26, 2016

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 — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
Marketing start: May 26, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 50268-634_4614f183-03ad-4459-e063-6294a90a391dSPL ID 4614f183-03ad-4459-e063-6294a90a391dSPL set ID 6b7d7d2f-a50b-8e21-2de4-ccc102016384RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 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

N450268063415 followed by a unit qualifier and the quantity

Package 50268-0634-15. 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 Dec 16, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine 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 is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 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 is indicated for the acute treatment of manic episodes associated with bipolar I d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-634

What is NDC 50268-634?: 50268-634 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 300 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, 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?: AvPAK, NDC labeler code 50268. 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?: 208 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 209 Quetiapine Fumarate 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	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	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6640
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6641
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6642
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6643
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-3359
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7881
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7894
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-8092
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0487
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-242
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-245
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-246
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-247
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-248
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-249
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-250
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4451
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1462

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