Trifluoperazine Hydrochloride NDC 0781-8036

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-8036Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-8036Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0781-8036-01	00781803601	100 TABLET, FILM COATED in 1 BOTTLE (0781-8036-01)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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sandoz Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 085788
Marketing start: Nov 20, 1981
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 0781-8036_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

N400781803601 followed by a unit qualifier and the quantity

Package 00781-8036-01. 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 Nov 30, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 085788

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 085788
Product	Strength	Form · route	Labeler	Product NDC
Trifluoperazine Hydrochloride	Trifluoperazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2205