Prescription drug · ANDA
Paroxetine NDC 68084-047
Paroxetine hydrochloride 40 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-047-01 | 6808400470168084004701 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-047-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-047-11)Marketed from Mar 15, 2005 |
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 hydrochloride — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 68084
- 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 68084-047_51b97a0a-6710-bf64-e063-6294a90ae626SPL ID 51b97a0a-6710-bf64-e063-6294a90ae626SPL set ID b5a8f864-a53d-48d9-aca6-6b64017fb168RxCUI 1738483, 1738495, 1738503, 1738511UNII 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
N468084004701followed by a unit qualifier and the quantityPackage 68084-0047-01. 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.
About NDC 68084-047
- What is NDC 68084-047?
- 68084-047 is the product NDC for Paroxetine, Paroxetine hydrochloride 40 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. 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 hydrochloride.
- Who is the labeler?
- American Health Packaging, NDC labeler code 68084. 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.
Related NDCs: other Paroxetine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4130 | 68788-4130-0168788-4130-0368788-4130-06+2 more |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0446 | 67046-0446-03 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0846 | 67046-0846-03 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-766 | 46708-0766-3046708-0766-91 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-766 | 62332-0766-3062332-0766-91 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-767 | 46708-0767-3046708-0767-91 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 37.5 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-768 | 46708-0768-3046708-0768-91 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-767 | 62332-0767-3062332-0767-91 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 37.5 mg/1 | Tablet, Film coated, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-768 | 62332-0768-3062332-0768-91 |
| Paroxetineparoxetine hydrochloride hemihydrate | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8829 | 68788-8829-0168788-8829-0368788-8829-06+2 more |
Other NDCs under ANDA 077584
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Paroxetine | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0850 |
| Paroxetine | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1297 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-972 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | DIRECT RX | 61919-513 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-105 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-190 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-434 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1840 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3349 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-097 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-098 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-099 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-601 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0446 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0846 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1740 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | NuCare Pharamceuticals, Inc. | 68071-2535 |
| Paroxetine | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-044 |
| Paroxetine | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-045 |
| Paroxetine | Paroxetine hydrochloride 30 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-046 |
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