What is NDC 33342-101?

33342-101 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 100 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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 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 33342-101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0101Add 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
33342-101-11	3334201011133342010111	100 TABLET, FILM COATED in 1 BOTTLE (33342-101-11)Marketed from Jun 14, 2016
33342-101-12	3334201011233342010112	10 BLISTER PACK in 1 CARTON (33342-101-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 14, 2016
33342-101-44	3334201014433342010144	1000 TABLET, FILM COATED in 1 BOTTLE (33342-101-44)Marketed from Jun 14, 2016

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
Generic name (nonproprietary): quetiapine fumarate
Active ingredients: Quetiapine fumarate — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203359
Marketing start: Jun 14, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 33342-101_e8676630-c511-427b-af62-969f338d96cfSPL ID e8676630-c511-427b-af62-969f338d96cfSPL set ID 531cbe20-dff2-4983-9788-4543079f83ffRxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0333342101440, 0333342103154, 0333342103444, 0333342104151
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

N433342010111 followed by a unit qualifier and the quantity

Package 33342-0101-11. 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 16, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablets are 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 tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets 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 tablets 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 tablets are indicated for the acute treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-101

What is NDC 33342-101?: 33342-101 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 100 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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?: 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 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 203359

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

FDA NDC Directory listings under ANDA 203359
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-099
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-100
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-103
Quetiapine fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-104
Quetiapine fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-105
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1362