What is NDC 72189-586?

72189-586 is the product NDC for Quetiapine Fumarate ER, Quetiapine fumarate 150 mg/1 tablet, film coated, extended release, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_rx, NDC labeler code 72189. 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 ER?

5 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 ER NDC 72189-586

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-586Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0586Add 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
72189-586-30	7218905863072189058630	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-586-30)Marketed from Oct 2, 2024

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 ER
Generic name (nonproprietary): quetiapine fumarate er
Active ingredients: Quetiapine fumarate — 150 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Direct_rxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209635
Marketing start: Oct 2, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-586_23820efc-4df8-9dc9-e063-6394a90a0bb4SPL ID 23820efc-4df8-9dc9-e063-6394a90a0bb4SPL set ID 23820efc-4df7-9dc9-e063-6394a90a0bb4RxCUI 895670UNII 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

N472189058630 followed by a unit qualifier and the quantity

Package 72189-0586-30. 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 Oct 2, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with SEROQUEL [see Clinical Studies (14.1)]. 1.2 Bipolar Disorder Quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of que…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-586

What is NDC 72189-586?: 72189-586 is the product NDC for Quetiapine Fumarate ER, Quetiapine fumarate 150 mg/1 tablet, film coated, extended release, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Quetiapine Fumarate ER.
What is the active ingredient?: Quetiapine fumarate.
Who is the labeler?: Direct_rx, NDC labeler code 72189. 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 ER?: 5 other product NDCs are listed under this name. See all Quetiapine Fumarate ER 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 ER NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Quetiapine Fumarate ER	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-642	72189-0642-30
Quetiapine Fumarate ER	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	Direct_Rx	72189-519	72189-0519-30
Quetiapine Fumarate ER	Quetiapine fumarate 150 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-481	72189-0481-30
Quetiapine Fumarate ER	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-482	72189-0482-30
Quetiapine Fumarate ER	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-483	72189-0483-30

Other NDCs under ANDA 209635

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

FDA NDC Directory listings under ANDA 209635
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-866
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc	50228-380
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc	50228-381
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc	50228-382
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc	50228-383
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc	50228-384
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4051
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coated, Extended releaseOral	Golden State Medical Supply, Inc.	51407-802
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coated, Extended releaseOral	Golden State Medical Supply, Inc.	51407-799
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coated, Extended releaseOral	Golden State Medical Supply, Inc.	51407-800
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	Golden State Medical Supply, Inc.	51407-801
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coated, Extended releaseOral	Golden State Medical Supply, Inc.	51407-803
Quetiapine Fumarate ER	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	Direct_Rx	72189-519
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coated, Extended releaseOral	ACI Healthcare USA, Inc.	71093-136
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coated, Extended releaseOral	ACI Healthcare USA, Inc.	71093-135
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coated, Extended releaseOral	ACI Healthcare USA, Inc.	71093-137
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coated, Extended releaseOral	ACI Healthcare USA, Inc.	71093-138
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coated, Extended releaseOral	ACI Healthcare USA, Inc.	71093-139
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coated, Extended releaseOral	NuCare Pharmaceuticals, Inc.	68071-3921
Quetiapine Extended Releasequetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4769