Prescription drug · ANDA
Paroxetine (Paroxetine hydrochloride) NDC 55154-7999
Paroxetine hydrochloride anhydrous 20 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-7999-0 | 5515479990055154799900 | 1 BLISTER PACK in 1 BAG (55154-7999-0) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 8, 2003 |
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 hydrochloride
- Active ingredients
- Paroxetine hydrochloride anhydrous — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075356
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-7999_224dfb62-6c9f-435c-b760-434430075a5cSPL ID 224dfb62-6c9f-435c-b760-434430075a5cSPL set ID 333dfd07-61f0-4b86-b4b5-b04adf64e49fRxCUI 1738495UNII 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
N455154799900followed by a unit qualifier and the quantityPackage 55154-7999-00. 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 tablets 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 55154-7999
- What is NDC 55154-7999?
- 55154-7999 is the product NDC for Paroxetine (paroxetine hydrochloride), Paroxetine hydrochloride anhydrous 20 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paroxetine (Paroxetine hydrochloride).
- What is the active ingredient?
- Paroxetine hydrochloride anhydrous.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 075356
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 |
|---|---|---|---|---|
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2871 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-317 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-492 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-992 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0993 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-736 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-734 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-735 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-737 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1460 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0083 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0084 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0097 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0101 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-5676 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-5677 |