Prescription drug · ANDA

Quetiapine NDC 0904-6643

Quetiapine fumarate 400 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6643Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6643Add 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
0904-6643-6100904664361100 BLISTER PACK in 1 CARTON (0904-6643-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 1, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
Marketing start
Listing expires
Identifiers
Product ID 0904-6643_493dac53-08c1-43d6-aeec-57b15b81609cSPL ID 493dac53-08c1-43d6-aeec-57b15b81609c
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

N400904664361 followed by a unit qualifier and the quantity

Package 00904-6643-61. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0904-6643

What is NDC 0904-6643?
0904-6643 is the product NDC for Quetiapine, Quetiapine fumarate 400 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, 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?
Major Pharmaceuticals, NDC labeler code 0904. 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 0904-6643 | National Drug Code | Med-Code