Prescription drug · ANDA
fluphenazine hydrochloride NDC 69238-1680
Fluphenazine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1680-1 | 69238168001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1680-1)Marketed from Jul 11, 2020 |
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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213647
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 69238-1680_e350dbeb-6212-43b1-8c85-f60fb1719e0fSPL ID e350dbeb-6212-43b1-8c85-f60fb1719e0fSPL set ID 5b443b30-5682-4cf3-9ed0-716efddbc865RxCUI 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
N469238168001followed by a unit qualifier and the quantityPackage 69238-1680-01. 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 213647
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 1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1678 |
| fluphenazine hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1679 |
| fluphenazine hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1681 |
| fluphenazine hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0975 |