What is NDC 33342-135?

33342-135 is the product NDC for Quetiapine, Quetiapine fumarate 200 mg/1 tablet, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?

86 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Quetiapine NDC 33342-135 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-135Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0135Add 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
33342-135-09	3334201350933342013509	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-135-09)Marketed from Nov 1, 2017
33342-135-15	3334201351533342013515	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-135-15)Marketed from Nov 1, 2017

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
Generic name (nonproprietary): quetiapine
Active ingredients: Quetiapine fumarate — 200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204253
Marketing start: Nov 1, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 33342-135_fb91b782-1195-4212-b130-9e078dc47dcdSPL ID fb91b782-1195-4212-b130-9e078dc47dcdSPL set ID d699b8c7-8a1c-44ed-85d8-c821a9c8c848RxCUI 721791, 721794, 721796, 895670UNII 2S3PL1B6UJUPC 0333342134158, 0333342137098, 0333342136091, 0333342135094, 0333342136152, 0333342137159, 0333342134097
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

N433342013509 followed by a unit qualifier and the quantity

Package 33342-0135-09. 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 Mar 30, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder, manic, or mixed episodes ( 1.2 ) • Bipolar disorder, depressive episodes ( 1.2 ) • Major depressive disorder, adjunctive therapy with antidepressants ( 1.3 ) 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-135

What is NDC 33342-135?: 33342-135 is the product NDC for Quetiapine, Quetiapine fumarate 200 mg/1 tablet, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Quetiapine.
What is the active ingredient?: Quetiapine fumarate.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?: 86 other product NDCs are listed under this name. See all Quetiapine 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4700	70518-4700-00
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4699	70518-4699-00
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0487	67046-0487-03
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1623	67046-1623-03
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4451	70518-4451-00
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4437	70518-4437-00
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4430	70518-4430-0070518-4430-01
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-598	68001-0598-06
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-599	68001-0599-06
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-600	68001-0600-06

All 87 Quetiapine NDCs

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 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
Quetiapine Fumarate ER	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-642