What is NDC 72189-642?

72189-642 is the product NDC for Quetiapine Fumarate ER, Quetiapine fumarate 400 mg/1 tablet, 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 72189-642

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-642Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0642Add 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
72189-642-30	7218906423072189064230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-642-30)Marketed from Sep 26, 2025

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 — 400 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204253
Marketing start: Sep 26, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-642_3fb5c81f-ce60-98bf-e063-6294a90a5711SPL ID 3fb5c81f-ce60-98bf-e063-6294a90a5711SPL set ID 3fb5c81f-ce5f-98bf-e063-6294a90a5711RxCUI 721796UNII 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

N472189064230 followed by a unit qualifier and the quantity

Package 72189-0642-30. 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 Sep 26, 2025. 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 quetiapine [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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-642

What is NDC 72189-642?: 72189-642 is the product NDC for Quetiapine Fumarate ER, Quetiapine fumarate 400 mg/1 tablet, 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 150 mg/1	Tablet, Film coated, Extended releaseOral	Direct_rx	72189-586	72189-0586-30
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 204253

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

FDA NDC Directory listings under ANDA 204253
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-134
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-135
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-136
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-137
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-5944
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4699
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4700