Prescription drug · ANDA

Quetiapine NDC 76420-519

Quetiapine fumarate 300 mg/1 · Tablet, Film coated · Oral · ASCLEMED USA INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)76420-519Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0519Add 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
76420-519-017642005190110 BLISTER PACK in 1 CARTON (76420-519-01) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 21, 2025
76420-519-107642005191010 TABLET, FILM COATED in 1 BOTTLE (76420-519-10)Marketed from Oct 21, 2025
76420-519-207642005192020 TABLET, FILM COATED in 1 BOTTLE (76420-519-20)Marketed from Oct 21, 2025
76420-519-307642005193030 TABLET, FILM COATED in 1 BOTTLE (76420-519-30)Marketed from Oct 21, 2025
76420-519-607642005196060 TABLET, FILM COATED in 1 BOTTLE (76420-519-60)Marketed from Oct 21, 2025
76420-519-907642005199090 TABLET, FILM COATED in 1 BOTTLE (76420-519-90)Marketed from Oct 21, 2025

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 — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
ASCLEMED USA INC.NDC labeler code 76420
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
Marketing start
Listing expires
Identifiers
Product ID 76420-519_41a41d6e-d9e9-4f2d-e063-6394a90aa6f5SPL ID 41a41d6e-d9e9-4f2d-e063-6394a90aa6f5SPL set ID 74e09734-26cb-42fe-b9a3-79cc10505e0bRxCUI 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

N476420051901 followed by a unit qualifier and the quantity

Package 76420-0519-01. 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 76420-519

What is NDC 76420-519?
76420-519 is the product NDC for Quetiapine, Quetiapine fumarate 300 mg/1 tablet, film coated, listed with the FDA by ASCLEMED USA INC.. It has 6 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?
ASCLEMED USA INC., NDC labeler code 76420. 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 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-248
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

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Quetiapine NDC 76420-519 | National Drug Code | Med-Code