What is NDC 50090-5884?

50090-5884 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 100 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Quetiapine Fumarate NDC 50090-5884

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-5884Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-5884Add 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
50090-5884-0	5009058840050090588400	30 TABLET in 1 BOTTLE (50090-5884-0)Marketed from Dec 22, 2021
50090-5884-1	5009058840150090588401	90 TABLET in 1 BOTTLE (50090-5884-1)Marketed from Dec 22, 2021

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 — 100 mg/1
Dosage form: Tablet
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: Mar 1, 2013
Listing expires: Dec 31, 2026
Identifiers: Product ID 50090-5884_5a3aca3c-b447-40dd-b79e-3b506791860dSPL ID 5a3aca3c-b447-40dd-b79e-3b506791860dSPL set ID ccacb909-8ee5-4223-bfee-9cfeae470ecfRxCUI 312743UNII 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

N450090588400 followed by a unit qualifier and the quantity

Package 50090-5884-00. 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 Nov 24, 2023. 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 50090-5884

What is NDC 50090-5884?: 50090-5884 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 100 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 2 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?: 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
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 fumarate	Quetiapine fumarate 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-074	87441-0074-01
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-073	87441-0073-01
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 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
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1519
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 Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1562
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6641
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7813
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 50 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-513
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-512
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-519
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-514
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-516
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-518
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-522
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Proficient Rx LP	71205-788
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-245
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-242
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-249
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-246

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