Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 63323-281
Fluphenazine hydrochloride 2.5 mg/mL · Injection, Solution · Intramuscular · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-281-10 | 6332302811063323028110 | 1 VIAL in 1 BOX (63323-281-10) / 10 mL in 1 VIALMarketed from Dec 28, 2010 |
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 Hydrochloride
- Generic name (nonproprietary)
- fluphenazine hydrochloride
- Active ingredients
- Fluphenazine hydrochloride — 2.5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089556
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 63323-281_cefdb059-d32b-44f2-8dd6-fd2a29b3ba70SPL ID cefdb059-d32b-44f2-8dd6-fd2a29b3ba70SPL set ID d571f04f-6190-42f2-932c-5a075fd978b9RxCUI 865129UNII ZOU145W1XL
- 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
N463323028110followed by a unit qualifier and the quantityPackage 63323-0281-10. 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 Injection, USP 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.
About NDC 63323-281
- What is NDC 63323-281?
- 63323-281 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride 2.5 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluphenazine Hydrochloride.
- What is the active ingredient?
- Fluphenazine hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 Hydrochloride?
- 99 other product NDCs are listed under this name. See all Fluphenazine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluphenazine 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) |
|---|---|---|---|---|---|
| fluphenazine hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0975 | 67046-0975-03 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4673 | 70518-4673-00 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-384 | 31722-0384-0131722-0384-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-385 | 31722-0385-0131722-0385-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-386 | 31722-0386-0131722-0386-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-387 | 31722-0387-0131722-0387-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1567 | 67046-1567-03 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1547 | 67046-1547-03 |
| Fluphenazine hydrochloride | Fluphenazine hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4273 | 70518-4273-0070518-4273-01 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-788 | 46708-0788-3146708-0788-71 |