Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 0121-0653
Fluphenazine hydrochloride 5 mg/mL · Solution, Concentrate · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0653-04 | 00121065304 | 120 mL in 1 BOTTLE, DROPPER (0121-0653-04)Marketed from Sep 1, 2010 |
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)
- Fluphenazine Hydrochloride
- Generic name (nonproprietary)
- fluphenazine hydrochloride
- Active ingredients
- Fluphenazine hydrochloride — 5 mg/mL
- Dosage form
- Solution, Concentrate
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074725
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 0121-0653_4bf945f4-e607-409c-80f5-90195005d6a7SPL ID 4bf945f4-e607-409c-80f5-90195005d6a7SPL set ID 0860b3f3-3116-40f8-bcb0-e5c47731bdc8RxCUI 861848UNII ZOU145W1XLUPC 0301210653049
- 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
N400121065304followed by a unit qualifier and the quantityPackage 00121-0653-04. 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 Fluphenazine hydrochloride is indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
Excerpt only. Read the full label for complete information.