Prescription drug · ANDA
fluphenazine hydrochloride NDC 62135-415
Fluphenazine hydrochloride 1 mg/1 · Tablet, Film coated · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-415-90 | 62135041590 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-415-90)Marketed from Oct 20, 2022 |
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 — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215141
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 62135-415_458c6457-ed15-15f4-e063-6294a90acc6dSPL ID 458c6457-ed15-15f4-e063-6294a90acc6dSPL set ID 325af2a4-2280-4236-8cf8-44f5700ba73fRxCUI 859841, 860918, 865117, 865123UNII ZOU145W1XLUPC 0362135416904, 0362135418908, 0362135419905, 0362135415907
- 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
N462135041590followed by a unit qualifier and the quantityPackage 62135-0415-90. 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 215141
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 2.5 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-122 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-121 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-123 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Zameer Pharmaceuticals LLC | 90096-124 |
| fluphenazine hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-419 |
| fluphenazine hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-416 |
| fluphenazine hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-418 |