Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 70771-1584
Fluphenazine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1584-1 | 70771158401 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1584-1)Marketed from May 28, 2021 | |
| 70771-1584-5 | 70771158405 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1584-5)Marketed from May 28, 2021 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214552
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 70771-1584_1db40261-ae57-4539-a7e9-7ca75d96627aSPL ID 1db40261-ae57-4539-a7e9-7ca75d96627aSPL set ID 977dc369-6b6d-4ad1-9239-a46f63a764bdRxCUI 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
N470771158401followed by a unit qualifier and the quantityPackage 70771-1584-01. 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 214552
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 | Zydus Lifesciences Limited | 70771-1583 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1581 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1582 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1490 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1488 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1489 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1491 |