Prescription drug · ANDA
Trifluoperazine Hydrochloride NDC 0378-2402
Trifluoperazine hydrochloride 2 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-2402-01 | 00378240201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2402-01)Marketed from Aug 29, 1997 |
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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040209
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 0378-2402_7586125c-d9c7-4c56-8ca8-8add657a91dbSPL ID 7586125c-d9c7-4c56-8ca8-8add657a91dbSPL set ID c2575a86-19e5-44df-8603-ff066bb9c9c5RxCUI 198322, 198323, 198324, 198325UNII 6P1Y2SNF5VUPC 0303782402018, 0303782405019
- 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
N400378240201followed by a unit qualifier and the quantityPackage 00378-2402-01. 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 hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride tablets are 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 hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040209
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 | Mylan Institutional Inc. | 51079-572 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 2 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-573 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-574 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-575 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-143 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-140 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 2 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-141 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-142 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-2401 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2095 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2106 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-2405 |
| Trifluoperazine Hydrochloride | Trifluoperazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-2410 |