Prescription drug · ANDA

Quetiapine NDC 67877-248

Quetiapine fumarate 400 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67877-248Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0248Add 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
67877-248-0167877024801100 TABLET, FILM COATED in 1 BOTTLE (67877-248-01)Marketed from Mar 1, 2013
67877-248-10678770248101000 TABLET, FILM COATED in 1 BOTTLE (67877-248-10)Marketed from Mar 1, 2013
67877-248-33678770248331 BLISTER PACK in 1 CARTON (67877-248-33) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 1, 2013
67877-248-386787702483810 BLISTER PACK in 1 CARTON (67877-248-38) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 1, 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
Generic name (nonproprietary)
quetiapine
Active ingredients
Quetiapine fumarate — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
Marketing start
Listing expires
Identifiers
Product ID 67877-248_1324eb95-6488-498f-b2c9-1c44b1f48062SPL ID 1324eb95-6488-498f-b2c9-1c44b1f48062SPL set ID 3112a006-1c61-47f2-84f5-9a7670d09c9bRxCUI 312743, 312744, 312745, 317174, 389201, 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

N467877024801 followed by a unit qualifier and the quantity

Package 67877-0248-01. 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 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 is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 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 is indicated for the acute treatment of manic episodes associated with bipolar I …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-248

What is NDC 67877-248?
67877-248 is the product NDC for Quetiapine, Quetiapine fumarate 400 mg/1 tablet, film coated, listed with the FDA by Ascend Laboratories, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Quetiapine.
What is the active ingredient?
Quetiapine fumarate.
Who is the labeler?
Ascend Laboratories, LLC, NDC labeler code 67877. 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?
86 other product NDCs are listed under this name. See all Quetiapine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-470070518-4700-00
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-469970518-4699-00
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-048767046-0487-03
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Extended releaseOralCoupler LLC67046-162367046-1623-03
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-445170518-4451-00
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-443770518-4437-00
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-443070518-4430-0070518-4430-01
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-59868001-0598-06
QuetiapineQuetiapine fumarate 150 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-59968001-0599-06
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-60068001-0600-06

All 87 Quetiapine NDCs

Other NDCs under ANDA 201504

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

FDA NDC Directory listings under ANDA 201504
ProductStrengthForm · routeLabelerProduct NDC
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralDirect_Rx72189-366
Quetiapine FumarateQuetiapine fumarate 50 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0186
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1709
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-242
QuetiapineQuetiapine fumarate 150 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-245
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-246
Quetiapine FumarateQuetiapine fumarate 100 mg/1TabletOralDirect Rx72189-340
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-247
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6638
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-249
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-250
Quetiapine FumarateQuetiapine fumarate 25 mg/1TabletOralProficient Rx LP71205-826
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6639
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7894
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6641
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4451
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3359
Quetiapine FumarateQuetiapine fumarate 100 mg/1TabletOralA-S Medication Solutions50090-5884
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3599
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-266

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