Prescription drug · ANDA

Quetiapine Fumarate (Quetiapine) NDC 50090-7471

Quetiapine fumarate 200 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7471Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7471Add 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
50090-7471-05009074710030 TABLET, FILM COATED in 1 BOTTLE (50090-7471-0)Marketed from Dec 12, 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
Active ingredients
Quetiapine fumarate — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
Marketing start
Listing expires
Identifiers
Product ID 50090-7471_d582eedc-0976-449b-ae78-7c0f62c0016cSPL ID d582eedc-0976-449b-ae78-7c0f62c0016cSPL set ID 10288afa-c4dc-4897-9ec8-f4573d850779RxCUI 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

N450090747100 followed by a unit qualifier and the quantity

Package 50090-7471-00. 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 bipolar I …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-7471

What is NDC 50090-7471?
50090-7471 is the product NDC for Quetiapine Fumarate (quetiapine), Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Quetiapine Fumarate (Quetiapine).
What is the active ingredient?
Quetiapine fumarate.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. 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?
214 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 215 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
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7813
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6639
Quetiapine FumarateQuetiapine fumarate 100 mg/1TabletOralProficient Rx LP82804-094
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6638
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6640
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1709
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-242
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6641
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-248
QuetiapineQuetiapine fumarate 150 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-245
Quetiapine FumarateQuetiapine fumarate 100 mg/1TabletOralDirect Rx72189-340
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-246
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-247
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-250
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-249
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6642
Quetiapine FumarateQuetiapine fumarate 25 mg/1TabletOralProficient Rx LP71205-826
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6643
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralDirect_Rx72189-366
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7881

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