Prescription drug · ANDA
Paroxetine (paroxetine hydrochloride) NDC 65841-601
Paroxetine hydrochloride anhydrous 40 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-601-01 | 65841060101 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-601-01)Marketed from Apr 13, 2007 | |
| 65841-601-05 | 65841060105 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-601-05)Marketed from Apr 13, 2007 | |
| 65841-601-06 | 65841060106 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-601-06)Marketed from Apr 13, 2007 | |
| 65841-601-10 | 65841060110 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-601-10)Marketed from Apr 13, 2007 | |
| 65841-601-16 | 65841060116 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-601-16)Marketed from Apr 13, 2007 |
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 hydrochloride
- Active ingredients
- Paroxetine hydrochloride anhydrous — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- 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 65841-601_ef5c1ef5-2884-4395-a65a-92591c986150SPL ID ef5c1ef5-2884-4395-a65a-92591c986150SPL set ID 6d5fcdb2-4d84-4b20-87e3-58a43e567500RxCUI 1738483, 1738495, 1738503, 1738511UNII 3I3T11UD2S
- 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
N465841060101followed by a unit qualifier and the quantityPackage 65841-0601-01. 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 .
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 hemihydrate 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0321 |
| Paroxetine | Paroxetine hydrochloride 40 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-6870 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3349 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0446 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc | 68788-0797 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-716 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-717 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-718 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-719 |
| Paroxetine | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0850 |
| Paroxetine | Paroxetine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7410 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-492 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-001 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0544 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | DIRECT RX | 61919-513 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-434 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2465 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3430 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc | 68788-9074 |
| Paroxetine | Paroxetine hydrochloride hemihydrate 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0846 |
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