What is NDC 47335-905?

47335-905 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 47335-905 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-905Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0905Add 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
47335-905-18	47335090518	1000 TABLET, FILM COATED in 1 BOTTLE (47335-905-18)Marketed from Mar 28, 2012
47335-905-61	47335090561	10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-905-61) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 28, 2012
47335-905-83	47335090583	30 TABLET, FILM COATED in 1 BOTTLE (47335-905-83)Marketed from Mar 28, 2012
47335-905-88	47335090588	100 TABLET, FILM COATED in 1 BOTTLE (47335-905-88)Marketed from Mar 28, 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 — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201190
Marketing start: Mar 28, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 47335-905_53310064-c86d-89f3-e063-6294a90a718bSPL ID 53310064-c86d-89f3-e063-6294a90a718bSPL set ID ffe52b98-9872-48c1-90fd-8fcd37c3432fRxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0347335907889, 0347335906882, 0347335905885, 0347335903881, 0347335904888
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

N447335090518 followed by a unit qualifier and the quantity

Package 47335-0905-18. 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 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine 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 manic ep…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-905

What is NDC 47335-905?: 47335-905 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 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 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 201190

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

FDA NDC Directory listings under ANDA 201190
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0772
Quetiapine fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-906
Quetiapine fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-907
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1440
Quetiapine fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2157
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2176
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-902
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-903
Quetiapine fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-904