Prescription drug · ANDA
Paroxetine NDC 61919-513
Paroxetine hydrochloride hemihydrate 40 mg/1 · Tablet, Film coated · Oral · DIRECT RX
NDC codes
FDA NDC DirectoryProduct NDC (as listed)61919-513Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0513Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-513-90 | 6191905139061919051390 | 90 TABLET, FILM COATED in 1 BOTTLE (61919-513-90)Marketed from Feb 29, 2016 |
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 hemihydrate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- DIRECT RXNDC labeler code 61919
- 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 61919-513_4c497215-c45a-4999-e063-6394a90a5cbdSPL ID 4c497215-c45a-4999-e063-6394a90a5cbdSPL set ID 2cfe30fc-9c46-4efd-e054-00144ff8d46cRxCUI 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
N461919051390followed by a unit qualifier and the quantityPackage 61919-0513-90. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE 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)
Excerpt only. Read the full label for complete information.
About NDC 61919-513
- What is NDC 61919-513?
- 61919-513 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 40 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. 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 hemihydrate.
- Who is the labeler?
- DIRECT RX, NDC labeler code 61919. 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 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 |
| Paroxetine | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-047 |
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