Prescription drug · ANDA

Paroxetine (paroxetine hydrochloride) NDC 0904-5677

Paroxetine hydrochloride anhydrous 20 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-5677Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-5677Add 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
0904-5677-6100904567761100 BLISTER PACK in 1 CARTON (0904-5677-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 8, 2003

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)
Paroxetine
Generic name (nonproprietary)
paroxetine hydrochloride
Active ingredients
Paroxetine hydrochloride anhydrous — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075356
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 0904-5677_1aadea03-718a-4b63-bb15-b23e171ad993SPL ID 1aadea03-718a-4b63-bb15-b23e171ad993
Pharmacologic class
Serotonin Reuptake Inhibitor

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

N400904567761 followed by a unit qualifier and the quantity

Package 00904-5677-61. 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.

Other NDCs under ANDA 075356

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

FDA NDC Directory listings under ANDA 075356
ProductStrengthForm · routeLabelerProduct NDC
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 20 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7999
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 40 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0993
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 40 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-737
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 10 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-734
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 20 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-735
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 30 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-736
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-5676
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 30 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1460
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 20 mg/1Tablet, Film coatedOralApotex Corp.60505-0083
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 30 mg/1Tablet, Film coatedOralApotex Corp.60505-0084
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 40 mg/1Tablet, Film coatedOralApotex Corp.60505-0101
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 10 mg/1Tablet, Film coatedOralApotex Corp.60505-0097
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC67544-317
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC67544-492
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2871
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride anhydrous 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-992

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Paroxetine (paroxetine hydrochloride) NDC 0904-5677 | Med-Code