NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1353Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1353Add 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
71335-1353-17133513530130 TABLET, FILM COATED in 1 BOTTLE (71335-1353-1)Marketed from Nov 5, 2019
71335-1353-27133513530260 TABLET, FILM COATED in 1 BOTTLE (71335-1353-2)Marketed from Oct 3, 2019
71335-1353-37133513530390 TABLET, FILM COATED in 1 BOTTLE (71335-1353-3)Marketed from Sep 26, 2019
71335-1353-47133513530425 TABLET, FILM COATED in 1 BOTTLE (71335-1353-4)Marketed from May 20, 2024
71335-1353-571335135305120 TABLET, FILM COATED in 1 BOTTLE (71335-1353-5)Marketed from May 20, 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 Fumarate
Generic name (nonproprietary)
quetiapine fumarate
Active ingredients
Quetiapine fumarate — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202674
Marketing start
Listing expires
Identifiers
Product ID 71335-1353_a2688211-bc1c-463d-90e5-47476a140965SPL ID a2688211-bc1c-463d-90e5-47476a140965SPL set ID 1618989e-2e6b-49ff-81b5-cf80d1dcfab4RxCUI 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

N471335135301 followed by a unit qualifier and the quantity

Package 71335-1353-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 202674

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

FDA NDC Directory listings under ANDA 202674
ProductStrengthForm · routeLabelerProduct NDC
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8473
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2175
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3747
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8470
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0184
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8471
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8472
Quetiapine FumarateQuetiapine fumarate 200 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-150
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-148
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-149
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-151
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8474
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-152
Quetiapine FumarateQuetiapine fumarate 400 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8568
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3377
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3931
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-147
Quetiapine FumarateQuetiapine fumarate 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3983
Quetiapine FumarateQuetiapine fumarate 50 mg/1Tablet, Film coatedOralCoupler LLC67046-1649

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