Prescription drug · ANDA

Quetiapine Fumarate NDC 68788-8530

Quetiapine fumarate 300 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8530Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8530Add 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
68788-8530-36878885300330 TABLET, FILM COATED in 1 BOTTLE (68788-8530-3)Marketed from Oct 6, 2023
68788-8530-66878885300660 TABLET, FILM COATED in 1 BOTTLE (68788-8530-6)Marketed from Oct 6, 2023
68788-8530-96878885300990 TABLET, FILM COATED in 1 BOTTLE (68788-8530-9)Marketed from Oct 6, 2023

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 Fumarate
Generic name (nonproprietary)
quetiapine fumarate
Active ingredients
Quetiapine fumarate — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091388
Marketing start
Listing expires
Identifiers
Product ID 68788-8530_76df809c-e4b7-4bc7-85c4-482212f459b2SPL ID 76df809c-e4b7-4bc7-85c4-482212f459b2SPL set ID 8acc0ed3-6e4f-4799-8252-5a163938fddcRxCUI 312745UNII 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

N468788853003 followed by a unit qualifier and the quantity

Package 68788-8530-03. 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 o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3609
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-1669
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2679
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralDirect_Rx72189-465
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2691
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8859
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralDirect_Rx72189-477
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6337
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2333
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3933
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9627
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9623
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-489
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3429
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralProficient Rx LP82804-020
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-493
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-490
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-491
Quetiapine FumarateQuetiapine fumarate 150 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-492
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralCoupler LLC67046-1588

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