Prescription drug · ANDA

Quetiapine Fumarate NDC 29300-150

Quetiapine fumarate 200 mg/1 · Tablet, Film coated · Oral · Unichem Pharmaceuticals (USA), Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)29300-150Labeler and product segments. Claims need a package NDC.
Product NDC at billing width29300-0150Add 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
29300-150-0129300015001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-01)Marketed from Jul 1, 2016
29300-150-10293000150101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-10)Marketed from May 23, 2017
29300-150-162930001501660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-16)Marketed from Jul 1, 2016

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 Fumarate
Generic name (nonproprietary)
quetiapine fumarate
Active ingredients
Quetiapine fumarate — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202674
Marketing start
Listing expires
Identifiers
Product ID 29300-150_9054a1a7-c7ea-4630-be0b-2dcbe910ca94SPL ID 9054a1a7-c7ea-4630-be0b-2dcbe910ca94SPL set ID bdc9354b-172e-4bb3-895a-6c7cfef0ef14RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0329300150162
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

N429300015001 followed by a unit qualifier and the quantity

Package 29300-0150-01. 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 tablets, USP 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, USP are indicated for the treatment of schizophrenia. The efficacy of Quetiapine tablets, USP 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, USP 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, USP are indicated fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202674

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

FDA NDC Directory listings under ANDA 202674
ProductStrengthForm · routeLabelerProduct NDC
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8473
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2175
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3747
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8470
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0184
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8471
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8472
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-148
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-149
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-151
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8474
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-152
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8568
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3377
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3931
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-147
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3983
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralCoupler LLC67046-1649
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1353

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Quetiapine Fumarate NDC 29300-150 | Med-Code