What is NDC 70518-3609?

70518-3609 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 300 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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?

211 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 70518-3609

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3609Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3609Add 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
70518-3609-0	7051836090070518360900	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3609-0)Marketed from Jan 4, 2023
70518-3609-1	7051836090170518360901	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3609-1)Marketed from Oct 16, 2025

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 Fumarate
Generic name (nonproprietary): quetiapine fumarate
Active ingredients: Quetiapine fumarate — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091388
Marketing start: Jan 4, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 70518-3609_4f6b0b54-8dd0-9d7b-e063-6294a90a44feSPL ID 4f6b0b54-8dd0-9d7b-e063-6294a90a44feSPL set ID da5c118f-404c-4453-aa10-a8656b1d7501RxCUI 312745UNII 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

N470518360900 followed by a unit qualifier and the quantity

Package 70518-3609-00. 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 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine tablets are 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 mani…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3609

What is NDC 70518-3609?: 70518-3609 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 300 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 2 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?: REMEDYREPACK INC., NDC labeler code 70518. 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?: 211 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 212 Quetiapine Fumarate NDCs

Other NDCs under ANDA 091388

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

FDA NDC Directory listings under ANDA 091388
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9697
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-718
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-717
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-722
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-719
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-720
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-721
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-375
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8530
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-380
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-376
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-377
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-378
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2333
Quetiapine Fumarate	Quetiapine fumarate 150 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-809
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8859
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3933
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-491
Quetiapine Fumarate	Quetiapine fumarate 25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-489
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-490

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