What is NDC 63187-269?

63187-269 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 100 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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 63187-269 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-269Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0269Add 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
63187-269-30	6318702693063187026930	30 TABLET, FILM COATED in 1 BOTTLE (63187-269-30)Marketed from Sep 1, 2014
63187-269-60	6318702696063187026960	60 TABLET, FILM COATED in 1 BOTTLE (63187-269-60)Marketed from Sep 1, 2014
63187-269-90	6318702699063187026990	90 TABLET, FILM COATED in 1 BOTTLE (63187-269-90)Marketed from Sep 1, 2014

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: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202152
Marketing start: Mar 26, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 63187-269_2fb97f0d-ad18-445a-b9a5-f128ae90cfc0SPL ID 2fb97f0d-ad18-445a-b9a5-f128ae90cfc0SPL set ID 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60RxCUI 312743, 616487UNII 2S3PL1B6UJUPC 0363187269302, 0363187219307
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

N463187026930 followed by a unit qualifier and the quantity

Package 63187-0269-30. 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 May 2, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine fumarate 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 fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate 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 fumarate 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 fumarate ta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-269

What is NDC 63187-269?: 63187-269 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 100 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 63187. 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 202152

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

FDA NDC Directory listings under ANDA 202152
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-452
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-7116
Quetiapine fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-219
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-4776
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-4841
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-4964
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-145
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-148
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-146
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-147
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-149
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-150
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-401