What is NDC 71610-702?

71610-702 is the product NDC for Quetiapine, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-702 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-702Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0702Add 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
71610-702-15	7161007021571610070215	15 TABLET, FILM COATED in 1 BOTTLE (71610-702-15)Marketed from Apr 18, 2023
71610-702-30	7161007023071610070230	30 TABLET, FILM COATED in 1 BOTTLE (71610-702-30)Marketed from Apr 18, 2023

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, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077745
Marketing start: May 25, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 71610-702_1b43ca4a-8d47-4085-b50f-b282980f39e3SPL ID 1b43ca4a-8d47-4085-b50f-b282980f39e3SPL set ID fdece055-aeb5-43d6-b730-54dd74bde304RxCUI 317174UNII 2S3PL1B6UJ
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

N471610070215 followed by a unit qualifier and the quantity

Package 71610-0702-15. 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 Apr 19, 2023. 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 is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 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 is indicated for the acute treatment of manic episodes associated with bipolar I…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-702

What is NDC 71610-702?: 71610-702 is the product NDC for Quetiapine, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 077745

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

FDA NDC Directory listings under ANDA 077745
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-2063
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-8162
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-8163
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-8164
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-8165
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-8166
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-026
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-402