Prescription drug · ANDA
Fluphenazine Hydrochoride (Fluphenazine hydrochloride) NDC 16571-891
Fluphenazine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-891-09 | 16571089109 | 90 TABLET, FILM COATED in 1 CONTAINER (16571-891-09)Marketed from Jun 7, 2024 | |
| 16571-891-50 | 16571089150 | 500 TABLET, FILM COATED in 1 CONTAINER (16571-891-50)Marketed from Jun 7, 2024 |
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 Hydrochoride
- Generic name (nonproprietary)
- fluphenazine hydrochloride
- Active ingredients
- Fluphenazine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218283
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 16571-891_5e7076f6-426b-45c2-865f-7be79fe81205SPL ID 5e7076f6-426b-45c2-865f-7be79fe81205SPL set ID 9fd44ab9-79bb-472e-8434-c3d786b42de5RxCUI 859841, 860918, 865117, 865123UNII 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 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
N416571089109followed by a unit qualifier and the quantityPackage 16571-0891-09. 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 & USAGE Fluphenazine hydrochloride tablets are 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 16571-891
- What is NDC 16571-891?
- 16571-891 is the product NDC for Fluphenazine Hydrochoride (fluphenazine hydrochloride), Fluphenazine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluphenazine Hydrochoride (Fluphenazine hydrochloride).
- What is the active ingredient?
- Fluphenazine hydrochloride.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 Hydrochoride?
- 4 other product NDCs are listed under this name. See all Fluphenazine Hydrochoride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluphenazine Hydrochoride 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 Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4691 | 70518-4691-00 |
| Fluphenazine Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-889 | 16571-0889-0916571-0889-50 |
| Fluphenazine Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-890 | 16571-0890-0916571-0890-50 |
| Fluphenazine Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-892 | 16571-0892-0916571-0892-50 |
Other NDCs under ANDA 218283
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 |
|---|---|---|---|---|
| Fluphenazine Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4691 |
| Fluphenazine Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-889 |
| Fluphenazine Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-890 |
| Fluphenazine Hydrochoridefluphenazine hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-892 |