Prescription drug · ANDA

Quetiapine Fumarate NDC 16571-717

Quetiapine fumarate 25 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)16571-717Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16571-0717Add 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
16571-717-0116571071701100 TABLET, FILM COATED in 1 BOTTLE (16571-717-01)Marketed from Mar 27, 2012
16571-717-10165710717101000 TABLET, FILM COATED in 1 BOTTLE (16571-717-10)Marketed from Mar 27, 2012

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 — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091388
Marketing start
Listing expires
Identifiers
Product ID 16571-717_b7aef4ea-0c7d-496f-b567-613189147c7eSPL ID b7aef4ea-0c7d-496f-b567-613189147c7eSPL set ID 532c8ace-4cf5-4a08-bae7-2af8c41ffa3dRxCUI 312743, 312744, 312745, 317174, 389201, 616483, 616487UNII 2S3PL1B6UJUPC 0316571719013, 0316571717019, 0316571718016
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

N416571071701 followed by a unit qualifier and the quantity

Package 16571-0717-01. 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 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 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 for the acute treatment of mani…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-717

What is NDC 16571-717?
16571-717 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 25 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 091388

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

FDA NDC Directory listings under ANDA 091388
ProductStrengthForm · routeLabelerProduct NDC
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-376
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-375
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-380
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-377
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-378
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-379
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9697
Quetiapine FumarateQuetiapine fumarate 150 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-809
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3609
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-1669
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2333
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6337
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3581
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8530
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2679
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2691
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralDirect_Rx72189-465
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralProficient Rx LP82804-020
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8859
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralDirect_Rx72189-477

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Quetiapine Fumarate NDC 16571-717 | National Drug Code | Med-Code