Prescription drug · ANDA

Quetiapine NDC 71205-401

Quetiapine fumarate 200 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0401Add 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
71205-401-30712050401307120504013030 TABLET, FILM COATED in 1 BOTTLE (71205-401-30)Marketed from Feb 13, 2020
71205-401-60712050401607120504016060 TABLET, FILM COATED in 1 BOTTLE (71205-401-60)Marketed from Feb 13, 2020
71205-401-90712050401907120504019090 TABLET, FILM COATED in 1 BOTTLE (71205-401-90)Marketed from Feb 13, 2020

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 — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202152
Marketing start
Listing expires
Identifiers
Product ID 71205-401_fbe8f179-fe43-43a4-b592-a31f2ec6aedeSPL ID fbe8f179-fe43-43a4-b592-a31f2ec6aedeSPL set ID 7a090720-fd90-4976-9aa2-41812106eb70RxCUI 317174UNII 2S3PL1B6UJUPC 0371205401306
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

N471205040130 followed by a unit qualifier and the quantity

Package 71205-0401-30. 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-401

What is NDC 71205-401?
71205-401 is the product NDC for Quetiapine, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?
Proficient Rx LP, NDC labeler code 71205. 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
QuetiapineQuetiapine fumarate 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-7116
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

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