Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 46708-791
Fluphenazine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-791-31 | 46708079131 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-791-31)Marketed from Jul 25, 2024 | |
| 46708-791-71 | 46708079171 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-791-71)Marketed from Jul 25, 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 Hydrochloride
- Generic name (nonproprietary)
- fluphenazine hydrochloride
- Active ingredients
- Fluphenazine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218173
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 46708-791_7c29fb1f-9403-4e55-abd9-36adfb152e8eSPL ID 7c29fb1f-9403-4e55-abd9-36adfb152e8eSPL set ID 7c29fb1f-9403-4e55-abd9-36adfb152e8eRxCUI 859841, 860918, 865117, 865123UNII ZOU145W1XLUPC 0346708788315, 0346708789312, 0346708791315, 0346708790318
- 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
N446708079131followed by a unit qualifier and the quantityPackage 46708-0791-31. 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 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.
Other NDCs under ANDA 218173
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 | Tablet, Film coatedOral | Coupler LLC | 67046-1547 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1567 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-791 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-788 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-789 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-790 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-790 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-788 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-789 |