Prescription drug · ANDA

Quetiapine NDC 29300-311

Quetiapine fumarate 300 mg/1 · Tablet, Extended release · Oral · Unichem Pharmaceuticals (USA), Inc.

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 NDC11-digit (billing)PackageCopy
29300-311-162930003111660 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215478
Marketing start
Listing expires
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 . 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)

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
ProductStrengthForm · routeLabelerProduct NDC
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4430
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4437
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2641
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-601
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-598
QuetiapineQuetiapine fumarate 150 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-599
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-600
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-602
QuetiapineQuetiapine fumarate 150 mg/1Tablet, Extended releaseOralUnichem Pharmaceuticals (USA), Inc.29300-309
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Extended releaseOralUnichem Pharmaceuticals (USA), Inc.29300-308
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Extended releaseOralUnichem Pharmaceuticals (USA), Inc.29300-312
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Extended releaseOralUnichem Pharmaceuticals (USA), Inc.29300-310
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Extended releaseOralCoupler LLC67046-1623

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Quetiapine NDC 29300-311 | Med-Code