Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 10135-727
Fluphenazine hydrochloride 5 mg/1 · Tablet · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-727-01 | 10135072701 | 100 TABLET in 1 BOTTLE (10135-727-01)Marketed from Jun 1, 2021 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214674
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 10135-727_437e142c-e2e3-2b97-e063-6294a90a9266SPL ID 437e142c-e2e3-2b97-e063-6294a90a9266SPL set ID c69f07b1-660c-db03-e053-2995a90a5464RxCUI 859841, 860918, 865117, 865123UNII ZOU145W1XLUPC 0310135725014, 0310135726011
- 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
N410135072701followed by a unit qualifier and the quantityPackage 10135-0727-01. 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 & 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 214674
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 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-725 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-726 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-728 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-275 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-273 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-274 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-276 |