Prescription drug · ANDA
Fluphenazine Decanoate NDC 67457-359
Fluphenazine decanoate 25 mg/mL · Injection, Solution · Intramuscular, Subcutaneous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-359-59 | 67457035959 | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-359-59) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 28, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Decanoate
- Generic name (nonproprietary)
- fluphenazine decanoate
- Active ingredients
- Fluphenazine decanoate — 25 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Subcutaneous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075918
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 67457-359_08baa8e5-a317-4529-9b2b-9a9c2ba5e7aeSPL ID 08baa8e5-a317-4529-9b2b-9a9c2ba5e7aeSPL set ID 3832d3d3-15ce-4d41-8431-11e9bd04cf4dRxCUI 859824UNII FMU62K1L3C
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467457035959followed by a unit qualifier and the quantityPackage 67457-0359-59. 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 Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection 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.
About NDC 67457-359
- What is NDC 67457-359?
- 67457-359 is the product NDC for Fluphenazine Decanoate, Fluphenazine decanoate 25 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluphenazine Decanoate.
- What is the active ingredient?
- Fluphenazine decanoate.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluphenazine Decanoate?
- 9 other product NDCs are listed under this name. See all Fluphenazine Decanoate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluphenazine Decanoate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluphenazine Decanoate | Fluphenazine decanoate 25 mg/mL | Injection, SolutionIntramuscular, Subcutaneous | Novadoz Pharmaceuticals LLC | 72205-100 | 72205-0100-01 |
| Fluphenazine Decanoate | Fluphenazine decanoate 25 mg/mL | Injection, SolutionIntramuscular, Subcutaneous | Bryant Ranch Prepack | 72162-2635 | 72162-2635-02 |
| Fluphenazine Decanoate | Fluphenazine decanoate 25 mg/mL | Injection, SolutionIntramuscular, Subcutaneous | Sagent Pharmaceuticals | 25021-838 | 25021-0838-05 |
| fluphenazine decanoate | Fluphenazine decanoate 25 mg/mL | Injection, SolutionIntramuscular, Subcutaneous | Gland Pharma Limited | 68083-476 | 68083-0476-01 |
| Fluphenazine Decanoate | Fluphenazine decanoate 25 mg/mL | Injection, SolutionIntramuscular, Subcutaneous | Par Health USA, LLC | 42023-129 | 42023-0129-89 |
| Fluphenazine Decanoate | Fluphenazine decanoate 125 mg/5mL | Injection, SolutionIntramuscular, Subcutaneous | Eugia US LLC | 55150-267 | 55150-0267-05 |
| Fluphenazine Decanoate | Fluphenazine decanoate 25 mg/mL | Injection, SolutionIntramuscular, Subcutaneous | Par Health USA, LLC | 42023-129 | 42023-0129-01 |
| Fluphenazine Decanoate | Fluphenazine decanoate 25 mg/mL | Injection, SolutionIntramuscular, Subcutaneous | Fresenius Kabi USA, LLC | 63323-272 | 63323-0272-05 |
| Fluphenazine Decanoate | Fluphenazine decanoate 25 mg/mL | InjectionIntramuscular, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9529 | 00143-9529-01 |