NDC codes

FDA NDC Directory
Product NDC (as listed)43547-409Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0409Add 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
43547-409-03435470409034354704090330 CAPSULE in 1 BOTTLE (43547-409-03)Marketed from Aug 15, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Active ingredients
Paroxetine mesylate — 7.5 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Solco Healthcare LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207188
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 43547-409_30b0c2b9-fb81-4015-ad28-12e658de0deaSPL ID 30b0c2b9-fb81-4015-ad28-12e658de0deaSPL set ID 2c5836c3-2099-452e-b6af-d2d50dc359fdRxCUI 1430122UNII M711N184JE
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

N443547040903 followed by a unit qualifier and the quantity

Package 43547-0409-03. 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)

Paroxetine capsules are indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitations of Use : Paroxetine capsules are not indicated for the treatment of any psychiatric condition. Paroxetine capsules have a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower paroxetine capsules dosage have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-409

What is NDC 43547-409?
43547-409 is the product NDC for Paroxetine, Paroxetine mesylate 7.5 mg/1 capsule, listed with the FDA by Solco Healthcare LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Paroxetine.
What is the active ingredient?
Paroxetine mesylate.
Who is the labeler?
Solco Healthcare LLC, NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Paroxetine?
145 other product NDCs are listed under this name. See all Paroxetine 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 Paroxetine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Paroxetineparoxetine hydrochloride hemihydrateParoxetine hydrochloride 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-413068788-4130-0168788-4130-0368788-4130-06+2 more
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralCoupler LLC67046-044667046-0446-03
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralCoupler LLC67046-084667046-0846-03
ParoxetineParoxetine hydrochloride hemihydrate 12.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Limited46708-76646708-0766-3046708-0766-91
ParoxetineParoxetine hydrochloride hemihydrate 12.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Inc.62332-76662332-0766-3062332-0766-91
ParoxetineParoxetine hydrochloride hemihydrate 25 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Limited46708-76746708-0767-3046708-0767-91
ParoxetineParoxetine hydrochloride hemihydrate 37.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Limited46708-76846708-0768-3046708-0768-91
ParoxetineParoxetine hydrochloride hemihydrate 25 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Inc.62332-76762332-0767-3062332-0767-91
ParoxetineParoxetine hydrochloride hemihydrate 37.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Inc.62332-76862332-0768-3062332-0768-91
Paroxetineparoxetine hydrochloride hemihydrateParoxetine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-882968788-8829-0168788-8829-0368788-8829-06+2 more

All 146 Paroxetine NDCs

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