Quetiapine NDC 43547-521

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-521Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0521Add 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
43547-521-10	43547052110	100 TABLET in 1 BOTTLE (43547-521-10)Marketed from Apr 12, 2022
43547-521-11	43547052111	1000 TABLET in 1 BOTTLE (43547-521-11)Marketed from Apr 12, 2022

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
Route: Oral
Labeler: Solco Healthcare US, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206954
Marketing start: Apr 12, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 43547-521_c91f8a6b-86e3-40a5-befe-4617aa36c718SPL ID c91f8a6b-86e3-40a5-befe-4617aa36c718SPL set ID 61b1230e-c0dc-46c6-a577-7d5dd2515eb7RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0343547519100, 0343547520106, 0343547518103, 0343547523107, 0343547522063, 0343547521103
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

N443547052110 followed by a unit qualifier and the quantity

Package 43547-0521-10. 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 Jul 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablets are 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 (13-17 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 treatmen…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206954

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

FDA NDC Directory listings under ANDA 206954
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine	Quetiapine fumarate 300 mg/1	TabletOral	Solco Healthcare US, LLC	43547-522
Quetiapine	Quetiapine fumarate 400 mg/1	TabletOral	Solco Healthcare US, LLC	43547-523
Quetiapine	Quetiapine fumarate 25 mg/1	TabletOral	Solco Healthcare US, LLC	43547-518
Quetiapine	Quetiapine fumarate 100 mg/1	TabletOral	Solco Healthcare US, LLC	43547-520
Quetiapine	Quetiapine fumarate 50 mg/1	TabletOral	Solco Healthcare US, LLC	43547-519