Prescription drug · ANDA
Fluphenazine hydrochloride NDC 70518-4273
Fluphenazine hydrochloride 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4273-0 | 70518427300 | 30 TABLET in 1 BLISTER PACK (70518-4273-0)Marketed from Feb 3, 2025 | |
| 70518-4273-1 | 70518427301 | 50 POUCH in 1 BOX (70518-4273-1) / 1 TABLET in 1 POUCH (70518-4273-2)Marketed from Apr 23, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217410
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 70518-4273_5025ebc2-a290-192f-e063-6294a90a0bceSPL ID 5025ebc2-a290-192f-e063-6294a90a0bceSPL set ID 85720b55-3419-4e2c-95dd-22eec035d6f1RxCUI 860918UNII 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
N470518427300followed by a unit qualifier and the quantityPackage 70518-4273-00. 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 tablets, USP are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride USP 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.
Other NDCs under ANDA 217410
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 hydrochloride | Fluphenazine hydrochloride 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-253 |
| Fluphenazine hydrochloride | Fluphenazine hydrochloride 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-252 |
| Fluphenazine hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-254 |
| Fluphenazine hydrochloride | Fluphenazine hydrochloride 1 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-255 |