Prescription drug · ANDA
Trifluoperazine Hydrochloride NDC 0781-8028
Trifluoperazine hydrochloride 1 mg/1 · Tablet, Film coated · Oral · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-8028-01 | 0078180280100781802801 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-8028-01)Marketed from Jan 14, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Trifluoperazine Hydrochloride
- Generic name (nonproprietary)
- trifluoperazine hydrochloride
- Active ingredients
- Trifluoperazine hydrochloride — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz Inc.NDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085785
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 0781-8028_79bbd43c-c3f3-4fa5-a2a4-88868251febbSPL ID 79bbd43c-c3f3-4fa5-a2a4-88868251febbSPL set ID ae43c10e-cfa9-4298-8af5-7a3e6524bbdaRxCUI 198322, 198323, 198324, 198325UNII 6P1Y2SNF5V
- Pharmacologic class
- Phenothiazine
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
N400781802801followed by a unit qualifier and the quantityPackage 00781-8028-01. 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)
INDICATIONS AND USAGE For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). When used in the treatment of non-psychotic anxiety, trifluoperazine HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irrever…
Excerpt only. Read the full label for complete information.
About NDC 0781-8028
- What is NDC 0781-8028?
- 0781-8028 is the product NDC for Trifluoperazine Hydrochloride, Trifluoperazine hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trifluoperazine Hydrochloride.
- What is the active ingredient?
- Trifluoperazine hydrochloride.
- Who is the labeler?
- Sandoz Inc., NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trifluoperazine Hydrochloride?
- 23 other product NDCs are listed under this name. See all Trifluoperazine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trifluoperazine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4686 | 70518-4686-00 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-140 | 48433-0140-20 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 2 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-141 | 48433-0141-20 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-142 | 48433-0142-20 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-143 | 48433-0143-20 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4554 | 70518-4554-00 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2106 | 70518-2106-00 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2095 | 70518-2095-00 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-572 | 51079-0572-20 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 2 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-573 | 51079-0573-20 |
Other NDCs under ANDA 085785
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 |
|---|---|---|---|---|
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2204 |