What is NDC 68180-446?

68180-446 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 50 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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?

213 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 68180-446 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0446Add 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
68180-446-01	68180044601	100 TABLET in 1 BOTTLE (68180-446-01)Marketed from Mar 27, 2012
68180-446-03	68180044603	1000 TABLET in 1 BOTTLE (68180-446-03)Marketed from Mar 27, 2012

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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
Marketing start: Mar 27, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 68180-446_e5317b83-f487-441b-9095-a25a9560bc54SPL ID e5317b83-f487-441b-9095-a25a9560bc54SPL set ID a951cd63-d329-47c9-965a-582fa73a07c6RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0368180445012, 0368180448013, 0368180450016
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

N468180044601 followed by a unit qualifier and the quantity

Package 68180-0446-01. 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 Jun 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablet 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 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 treatment of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-446

What is NDC 68180-446?: 68180-446 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 50 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc.. 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?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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?: 213 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 fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-073	87441-0073-01
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-074	87441-0074-01
Quetiapine fumaratequetiapine	Quetiapine fumarate 100 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-072	87441-0072-01
Quetiapine fumaratequetiapine	Quetiapine fumarate 50 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-071	87441-0071-01
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 214 Quetiapine fumarate NDCs

Other NDCs under ANDA 201109

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

FDA NDC Directory listings under ANDA 201109
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine fumarate	Quetiapine fumarate 400 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-450
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-447
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-448
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8745
Quetiapine fumarate	Quetiapine fumarate 300 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-449
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8746
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	REMEDYREPACK INC.	70518-1918
Quetiapine fumarate	Quetiapine fumarate 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-1919
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	TabletOral	: Preferred Pharmaceuticals Inc.	68788-8764
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-8778
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-2102
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-098
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-2422
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2428
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-763
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-762
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3676
Quetiapine fumarate	Quetiapine fumarate 300 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3940
Quetiapine fumarate	Quetiapine fumarate 400 mg/1	TabletOral	Bryant Ranch Prepack	71335-2462
Quetiapine fumaratequetiapine	Quetiapine fumarate 200 mg/1	TabletOral	Coupler LLC	67046-0637

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