Prescription drug · ANDA

Quetiapine fumarate (Quetiapine) NDC 68001-183

Quetiapine fumarate 300 mg/1 · Tablet · Oral · BluePoint Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)68001-183Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0183Add 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
68001-183-0068001018300100 TABLET in 1 BOTTLE (68001-183-00)Marketed from Feb 28, 2013
68001-183-0368001018303500 TABLET in 1 BOTTLE (68001-183-03)Marketed from Feb 28, 2013
68001-183-066800101830660 TABLET in 1 BOTTLE (68001-183-06)Marketed from Feb 28, 2013

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
Active ingredients
Quetiapine fumarate — 300 mg/1
Dosage form
Tablet
Route
Oral
Labeler
BluePoint LaboratoriesNDC labeler code 68001
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
Marketing start
Listing expires
Identifiers
Product ID 68001-183_4e775bd2-4ec9-32b4-e063-6294a90acf3dSPL ID 4e775bd2-4ec9-32b4-e063-6294a90acf3dSPL set ID 874e50ad-5da0-4ac3-9290-79442c91399eRxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0368001184007, 0368001185004, 0368001180009, 0368001182003, 0368001181006, 0368001183062
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

N468001018300 followed by a unit qualifier and the quantity

Package 68001-0183-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Quetiapine tablet is 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 fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68001-183

What is NDC 68001-183?
68001-183 is the product NDC for Quetiapine fumarate (quetiapine), Quetiapine fumarate 300 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Quetiapine fumarate (Quetiapine).
What is the active ingredient?
Quetiapine fumarate.
Who is the labeler?
BluePoint Laboratories, NDC labeler code 68001. 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 fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralUnit Dose Solutions, Inc.87441-07387441-0073-01
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralUnit Dose Solutions, Inc.87441-07487441-0074-01
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 201109

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

FDA NDC Directory listings under ANDA 201109
ProductStrengthForm · routeLabelerProduct NDC
Quetiapine fumarateQuetiapine fumarate 200 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-098
Quetiapine fumarateQuetiapine fumarate 400 mg/1TabletOralREMEDYREPACK INC.70518-2752
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-445
Quetiapine fumarateQuetiapine fumarate 50 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-446
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-447
Quetiapine fumarateQuetiapine fumarate 200 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-448
Quetiapine fumarateQuetiapine fumarate 300 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-449
Quetiapine fumarateQuetiapine fumarate 400 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-450
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8745
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-095
Quetiapine fumarateQuetiapine fumarate 200 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8746
Quetiapine fumarateQuetiapine fumarate 50 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-096
Quetiapine fumarateQuetiapine fumarate 50 mg/1TabletOralREMEDYREPACK INC.70518-2901
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-097
Quetiapine fumarateQuetiapine fumarate 200 mg/1TabletOralREMEDYREPACK INC.70518-1918
Quetiapine fumarateQuetiapine fumarate 300 mg/1TabletOralREMEDYREPACK INC.70518-1919
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOral: Preferred Pharmaceuticals Inc.68788-8764
Quetiapine fumarateQuetiapine fumarate 50 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-8778
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralREMEDYREPACK INC.70518-2102
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-762

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Quetiapine fumarate NDC 68001-183 | National Drug Code | Med-Code