Prescription drug · ANDA

Quetiapine fumarate (Quetiapine) NDC 60687-382

Quetiapine fumarate 400 mg/1 · Tablet · Oral · American Health Packaging

NDC codes

FDA NDC Directory
Product NDC (as listed)60687-382Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0382Add 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
60687-382-0160687038201100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-382-01) / 1 TABLET in 1 BLISTER PACK (60687-382-11)Marketed from Oct 3, 2017

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 — 400 mg/1
Dosage form
Tablet
Route
Oral
Labeler
American Health PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
Marketing start
Listing expires
Identifiers
Product ID 60687-382_5254e16c-9c61-9496-e063-6394a90a7526SPL ID 5254e16c-9c61-9496-e063-6394a90a7526SPL set ID 9f927ae2-a0ae-4953-99ba-8de59ee5bfcaRxCUI 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

N460687038201 followed by a unit qualifier and the quantity

Package 60687-0382-01. 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 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 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 are indicated for the acute treatment of man…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60687-382

What is NDC 60687-382?
60687-382 is the product NDC for Quetiapine fumarate (quetiapine), Quetiapine fumarate 400 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, 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?
American Health Packaging, NDC labeler code 60687. 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 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 fumaratequetiapineQuetiapine fumarate 400 mg/1TabletOralBluePoint Laboratories68001-181
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralBluePoint Laboratories68001-182
Quetiapine fumaratequetiapineQuetiapine fumarate 300 mg/1TabletOralBluePoint Laboratories68001-183
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralBryant Ranch Prepack71335-2428
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3676
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralA-S Medication Solutions50090-6812
Quetiapine fumarateQuetiapine fumarate 300 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3940
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralCoupler LLC67046-0632
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralCoupler LLC67046-0636
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralCoupler LLC67046-0637
Quetiapine fumaratequetiapineQuetiapine fumarate 300 mg/1TabletOralCoupler LLC67046-0638
Quetiapine fumarateQuetiapine fumarate 400 mg/1TabletOralBryant Ranch Prepack71335-2462
Quetiapine fumaratequetiapineQuetiapine fumarate 50 mg/1TabletOralBluePoint Laboratories68001-180
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0413
Quetiapine fumaratequetiapineQuetiapine fumarate 25 mg/1TabletOralAmerican Health Packaging60687-327
Quetiapine fumaratequetiapineQuetiapine fumarate 50 mg/1TabletOralAmerican Health Packaging60687-338
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralAmerican Health Packaging60687-360
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralAmerican Health Packaging60687-349
Quetiapine fumaratequetiapineQuetiapine fumarate 300 mg/1TabletOralAmerican Health Packaging60687-371
Quetiapine fumaratequetiapineQuetiapine fumarate 25 mg/1TabletOralCoupler LLC67046-1116

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in