Prescription drug · ANDA

Quetiapine NDC 63629-7116

Quetiapine fumarate 400 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-7116Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-7116Add 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
63629-7116-1636297116016362971160130 TABLET, FILM COATED in 1 BOTTLE (63629-7116-1)Marketed from Oct 17, 2016
63629-7116-2636297116026362971160228 TABLET, FILM COATED in 1 BOTTLE (63629-7116-2)Marketed from Aug 8, 2024
63629-7116-3636297116036362971160360 TABLET, FILM COATED in 1 BOTTLE (63629-7116-3)Marketed from Sep 19, 2017
63629-7116-46362971160463629711604180 TABLET, FILM COATED in 1 BOTTLE (63629-7116-4)Marketed from Dec 18, 2017
63629-7116-5636297116056362971160590 TABLET, FILM COATED in 1 BOTTLE (63629-7116-5)Marketed from Aug 8, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202152
Marketing start
Listing expires
Identifiers
Product ID 63629-7116_e4115f00-9922-479a-9523-391357dd406dSPL ID e4115f00-9922-479a-9523-391357dd406dSPL set ID cb989abf-7d73-4ab9-a07f-a8c9de50389fRxCUI 616483UNII 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

N463629711601 followed by a unit qualifier and the quantity

Package 63629-7116-01. 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 tablet is 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 tablet is indicated for the acute treatment of manic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-7116

What is NDC 63629-7116?
63629-7116 is the product NDC for Quetiapine, Quetiapine fumarate 400 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 202152

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

FDA NDC Directory listings under ANDA 202152
ProductStrengthForm · routeLabelerProduct NDC
Quetiapine fumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralProficient Rx LP63187-452
Quetiapine fumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralProficient Rx LP63187-219
Quetiapine fumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-269
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4776
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4841
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4964
QuetiapineQuetiapine fumarate 25 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-145
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-148
QuetiapineQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-146
QuetiapineQuetiapine fumarate 100 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-147
QuetiapineQuetiapine fumarate 300 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-149
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-150
QuetiapineQuetiapine fumarate 200 mg/1Tablet, Film coatedOralProficient Rx LP71205-401

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