NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7410Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7410Add 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
68788-7410-16878874100168788741001100 TABLET, FILM COATED in 1 BOTTLE (68788-7410-1)Marketed from Jun 6, 2018
68788-7410-2687887410026878874100228 TABLET, FILM COATED in 1 BOTTLE (68788-7410-2)Marketed from Jun 6, 2018
68788-7410-3687887410036878874100330 TABLET, FILM COATED in 1 BOTTLE (68788-7410-3)Marketed from Jun 6, 2018
68788-7410-6687887410066878874100660 TABLET, FILM COATED in 1 BOTTLE (68788-7410-6)Marketed from Jun 6, 2018
68788-7410-86878874100868788741008120 TABLET, FILM COATED in 1 BOTTLE (68788-7410-8)Marketed from Jun 6, 2018
68788-7410-9687887410096878874100990 TABLET, FILM COATED in 1 BOTTLE (68788-7410-9)Marketed from Jun 6, 2018

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)
Paroxetine
Generic name (nonproprietary)
paroxetine
Active ingredients
Paroxetine hydrochloride — 30 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077584
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68788-7410_4a943755-3972-42c2-8e1e-7fe8aabaedf5SPL ID 4a943755-3972-42c2-8e1e-7fe8aabaedf5SPL set ID ee38b589-e646-4203-bea5-cc3744fe17c3RxCUI 1738503UNII 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.

NDC on a medical claim

N468788741001 followed by a unit qualifier and the quantity

Package 68788-7410-01. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Paroxetine tablets are indicated in adults for the treatment of: • Major depressive disorder (MDD) • Obsessive compulsive disorder (OCD) • Panic disorder (PD) • Social anxiety disorder (SAD) • Generalized anxiety disorder (GAD) • Posttraumatic stress disorder (PTSD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): • Major Depressive Disorder (MDD) • Obsessive Compulsive Disorder (OCD) • Panic Disorder (PD) • Social Anxiety Disorder (SAD) • Generalized Anxiety Disorder (GAD) • Posttraumatic Stress Disorder (PTSD)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-7410

What is NDC 68788-7410?
68788-7410 is the product NDC for Paroxetine, Paroxetine hydrochloride 30 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Paroxetine.
What is the active ingredient?
Paroxetine hydrochloride.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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

Other NDCs under ANDA 077584

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

FDA NDC Directory listings under ANDA 077584
ProductStrengthForm · routeLabelerProduct NDC
ParoxetineParoxetine hydrochloride 10 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-044
ParoxetineParoxetine hydrochloride 40 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-6870
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-1740
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-190
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3349
ParoxetineParoxetine hydrochloride 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0850
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralCoupler LLC67046-0446
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc68788-0797
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-716
ParoxetineParoxetine hydrochloride hemihydrate 20 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-717
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-718
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0321
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-719
ParoxetineParoxetine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1297
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralDIRECT RX61919-513
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralProficient Rx LP63187-434
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2465
ParoxetineParoxetine hydrochloride 20 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-045
ParoxetineParoxetine hydrochloride 30 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-046
ParoxetineParoxetine hydrochloride 40 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-047

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