Prescription drug · ANDA

Quetiapine Fumarate NDC 0615-8472

Quetiapine fumarate 100 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8472Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8472Add 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
0615-8472-05006158472050061584720515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8472-05)Marketed from May 4, 2023
0615-8472-39006158472390061584723930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8472-39)Marketed from May 4, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202674
Marketing start
Listing expires
Identifiers
Product ID 0615-8472_9f55185f-8471-4477-97b2-b61dd50c8b44SPL ID 9f55185f-8471-4477-97b2-b61dd50c8b44SPL set ID d73655d3-4b3f-40b4-92cb-053ad4f21a92RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 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

N400615847205 followed by a unit qualifier and the quantity

Package 00615-8472-05. 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)

About NDC 0615-8472

What is NDC 0615-8472?
0615-8472 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 100 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?
NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?
214 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470170518-4701-00
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470570518-4705-00
Quetiapine fumaratequetiapineQuetiapine fumarate 25 mg/1TabletOralCoupler LLC67046-111667046-1116-03
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralUnit Dose Solutions, Inc.87441-07487441-0074-01
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralUnit Dose Solutions, Inc.87441-07387441-0073-01
Quetiapine fumaratequetiapineQuetiapine fumarate 50 mg/1TabletOralUnit Dose Solutions, Inc.87441-07187441-0071-01
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralUnit Dose Solutions, Inc.87441-07287441-0072-01
Quetiapine fumaratequetiapineQuetiapine fumarate 300 mg/1TabletOralCoupler LLC67046-063867046-0638-03
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralCoupler LLC67046-063667046-0636-03
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralCoupler LLC67046-063767046-0637-03

All 215 Quetiapine Fumarate NDCs

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 25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8470
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8471
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8473
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8474
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8568
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-147
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 200 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-150
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-151
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-152
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3377
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 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3931
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 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1353
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0184

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