Prescription drug · ANDA

Quetiapine Fumarate NDC 68788-8823

Quetiapine fumarate 25 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8823Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8823Add 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 NDC11-digit (billing)PackageCopy
68788-8823-16878888230168788882301100 TABLET in 1 BOTTLE (68788-8823-1)Marketed from Feb 10, 2025
68788-8823-3687888823036878888230330 TABLET in 1 BOTTLE (68788-8823-3)Marketed from Feb 10, 2025
68788-8823-6687888823066878888230660 TABLET in 1 BOTTLE (68788-8823-6)Marketed from Feb 10, 2025
68788-8823-86878888230868788882308120 TABLET in 1 BOTTLE (68788-8823-8)Marketed from Feb 10, 2025
68788-8823-9687888823096878888230990 TABLET in 1 BOTTLE (68788-8823-9)Marketed from Feb 10, 2025

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 — 25 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 201504
Marketing start
Listing expires
Identifiers
Product ID 68788-8823_69275af7-1469-4405-a98e-e8b0f8d42dd9SPL ID 69275af7-1469-4405-a98e-e8b0f8d42dd9SPL set ID 69275af7-1469-4405-a98e-e8b0f8d42dd9RxCUI 312744UNII 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

N468788882301 followed by a unit qualifier and the quantity

Package 68788-8823-01. 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 . 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 bipo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8823

What is NDC 68788-8823?
68788-8823 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 25 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?
211 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470170518-4701-00
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470570518-4705-00
Quetiapine fumaratequetiapineQuetiapine fumarate 25 mg/1TabletOralCoupler LLC67046-111667046-1116-03
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralUnit Dose Solutions, Inc.87441-07387441-0073-01
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralUnit Dose Solutions, Inc.87441-07487441-0074-01
Quetiapine fumaratequetiapineQuetiapine fumarate 50 mg/1TabletOralUnit Dose Solutions, Inc.87441-07187441-0071-01
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralUnit Dose Solutions, Inc.87441-07287441-0072-01
Quetiapine fumaratequetiapineQuetiapine fumarate 300 mg/1TabletOralCoupler LLC67046-063867046-0638-03
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralCoupler LLC67046-063667046-0636-03
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralCoupler LLC67046-063767046-0637-03

All 212 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
ProductStrengthForm · routeLabelerProduct NDC
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6638
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6639
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6640
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6641
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6642
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6643
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3359
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7881
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7894
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-8092
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-0487
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-242
QuetiapineQuetiapine fumarate 150 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-245
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-246
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-247
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-248
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-249
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-250
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4451
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1462

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