What is NDC 29300-311?

29300-311 is the product NDC for Quetiapine, Quetiapine fumarate 300 mg/1 tablet, extended release, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. 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 29300-311 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-311Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0311Add 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
29300-311-16	2930003111629300031116	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-311-16)Marketed from Sep 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 — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.NDC labeler code 29300
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215478
Marketing start: Aug 15, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 29300-311_c5ece454-9c87-42df-a9f9-fc9806d7c312SPL ID c5ece454-9c87-42df-a9f9-fc9806d7c312SPL set ID 61695b42-cf71-43e3-8b5d-788fd439489fRxCUI 721791, 721794, 721796, 853201, 895670UNII 2S3PL1B6UJUPC 0329300311167, 0329300312164, 0329300310160, 0329300309164
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

N429300031116 followed by a unit qualifier and the quantity

Package 29300-0311-16. 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 Feb 21, 2025. 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, or mixed episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) Major depressive disorder, adjunctive therapy with antidepressants ( 1.3 ) 1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine table…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 29300-311

What is NDC 29300-311?: 29300-311 is the product NDC for Quetiapine, Quetiapine fumarate 300 mg/1 tablet, extended release, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. 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?: Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. 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 215478

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

FDA NDC Directory listings under ANDA 215478
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1623
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4430
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4437
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-310
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-308
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-309
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-312
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2641
Quetiapine	Quetiapine fumarate 50 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-598
Quetiapine	Quetiapine fumarate 150 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-599
Quetiapine	Quetiapine fumarate 200 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-600
Quetiapine	Quetiapine fumarate 300 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-601
Quetiapine	Quetiapine fumarate 400 mg/1	Tablet, Extended releaseOral	BluePoint Laboratories	68001-602