What is NDC 67046-0487?

67046-0487 is the product NDC for Quetiapine, Quetiapine fumarate 100 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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 67046-0487 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-0487Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-0487Add 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
67046-0487-3	6704604870367046048703	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0487-3)Marketed from Jul 7, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
Marketing start: Jul 7, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 67046-0487_5605249c-4e4c-8eb0-e063-6394a90a8145SPL ID 5605249c-4e4c-8eb0-e063-6394a90a8145SPL set ID 56052e5c-0b0b-c296-e063-6394a90a5ad6RxCUI 312743UNII 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

N467046048703 followed by a unit qualifier and the quantity

Package 67046-0487-03. 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 7, 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 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 67046-0487

What is NDC 67046-0487?: 67046-0487 is the product NDC for Quetiapine, Quetiapine fumarate 100 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?: Coupler LLC, NDC labeler code 67046. 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 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
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-601	68001-0601-06

All 87 Quetiapine NDCs

Other NDCs under ANDA 201504

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

FDA NDC Directory listings under ANDA 201504
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1519
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6638
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6639
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1562
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6641
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7813
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6642
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6643
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-513
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-512
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-519
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	TabletOral	A-S Medication Solutions	50090-5884
Quetiapine	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-514
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-516
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-518
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	76420-522
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Proficient Rx LP	71205-788
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-245
Quetiapine	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-242
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-249

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