NDC codes

FDA NDC Directory
Product NDC (as listed)68180-647Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0647Add the package segment from the table below.

Product information

Brand name (proprietary)
Paroxetine
Generic name (nonproprietary)
paroxetine
Active ingredients
Paroxetine hydrochloride hemihydrate — 12.5 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204134
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68180-647_1a9bc25c-db83-42a0-851a-30212ee10cc6SPL ID 1a9bc25c-db83-42a0-851a-30212ee10cc6SPL set ID d315e0da-f829-408b-be5d-2bca2e06913cRxCUI 1738803, 1738805, 1738807UNII X2ELS050D8
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.

Product label

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

Other NDCs under ANDA 204134

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

FDA NDC Directory listings under ANDA 204134
ProductStrengthForm · routeLabelerProduct NDC
ParoxetineParoxetine hydrochloride hemihydrate 37.5 mg/1Tablet, Film coated, Extended releaseOralLupin Pharmaceuticals, Inc.68180-645
ParoxetineParoxetine hydrochloride hemihydrate 25 mg/1Tablet, Film coated, Extended releaseOralLupin Pharmaceuticals, Inc.68180-646

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