What is NDC 68788-8746?

68788-8746 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 200 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 68788-8746 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8746Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8746Add 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
68788-8746-1	68788874601	100 TABLET in 1 BOTTLE (68788-8746-1)Marketed from Sep 26, 2024
68788-8746-3	68788874603	30 TABLET in 1 BOTTLE (68788-8746-3)Marketed from Sep 26, 2024
68788-8746-6	68788874606	60 TABLET in 1 BOTTLE (68788-8746-6)Marketed from Sep 26, 2024
68788-8746-8	68788874608	120 TABLET in 1 BOTTLE (68788-8746-8)Marketed from Sep 26, 2024
68788-8746-9	68788874609	90 TABLET in 1 BOTTLE (68788-8746-9)Marketed from Sep 26, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
Marketing start: Sep 26, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 68788-8746_79eff2cb-a53e-4b31-a914-6f68d92b73b4SPL ID 79eff2cb-a53e-4b31-a914-6f68d92b73b4SPL set ID 711f42c5-0719-46de-81fb-3d03801b9ed9RxCUI 312743, 317174UNII 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

N468788874601 followed by a unit qualifier and the quantity

Package 68788-8746-01. 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 Aug 25, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablet 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 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 treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8746

What is NDC 68788-8746?: 68788-8746 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 200 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 201109

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

FDA NDC Directory listings under ANDA 201109
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	A-S Medication Solutions	50090-6812
Quetiapine fumaratequetiapine	Quetiapine fumarate 25 mg/1	TabletOral	American Health Packaging	60687-327
Quetiapine fumaratequetiapine	Quetiapine fumarate 50 mg/1	TabletOral	American Health Packaging	60687-338
Quetiapine fumaratequetiapine	Quetiapine fumarate 100 mg/1	TabletOral	American Health Packaging	60687-349
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	American Health Packaging	60687-360
Quetiapine fumaratequetiapine	Quetiapine fumarate 300 mg/1	TabletOral	American Health Packaging	60687-371
Quetiapine fumaratequetiapine	Quetiapine fumarate 400 mg/1	TabletOral	American Health Packaging	60687-382
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-762
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-763
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Coupler LLC	67046-0632
Quetiapine fumaratequetiapine	Quetiapine fumarate 100 mg/1	TabletOral	Coupler LLC	67046-0636
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	Coupler LLC	67046-0637
Quetiapine fumaratequetiapine	Quetiapine fumarate 300 mg/1	TabletOral	Coupler LLC	67046-0638
Quetiapine fumaratequetiapine	Quetiapine fumarate 25 mg/1	TabletOral	Coupler LLC	67046-1116
Quetiapine fumaratequetiapine	Quetiapine fumarate 50 mg/1	TabletOral	BluePoint Laboratories	68001-180
Quetiapine fumaratequetiapine	Quetiapine fumarate 400 mg/1	TabletOral	BluePoint Laboratories	68001-181
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	BluePoint Laboratories	68001-182
Quetiapine fumaratequetiapine	Quetiapine fumarate 300 mg/1	TabletOral	BluePoint Laboratories	68001-183
Quetiapine fumaratequetiapine	Quetiapine fumarate 100 mg/1	TabletOral	BluePoint Laboratories	68001-184
Quetiapine fumaratequetiapine	Quetiapine fumarate 25 mg/1	TabletOral	BluePoint Laboratories	68001-185

Showing 20 of 39.