Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 59651-688
Fluphenazine hydrochloride 5 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-688-01 | 59651068801 | 100 TABLET in 1 BOTTLE (59651-688-01)Marketed from Aug 18, 2023 | |
| 59651-688-05 | 59651068805 | 500 TABLET in 1 BOTTLE (59651-688-05)Marketed from Aug 18, 2023 |
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
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218055
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 59651-688_1109b107-f7af-45b7-b8ee-709c59123074SPL ID 1109b107-f7af-45b7-b8ee-709c59123074SPL set ID e73764e7-e666-4ad3-a029-04a528dc1c9eRxCUI 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
N459651068801followed by a unit qualifier and the quantityPackage 59651-0688-01. 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.
About NDC 59651-688
- What is NDC 59651-688?
- 59651-688 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride 5 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluphenazine Hydrochloride.
- What is the active ingredient?
- Fluphenazine hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluphenazine Hydrochloride?
- 101 other product NDCs are listed under this name. See all Fluphenazine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluphenazine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| fluphenazine hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0975 | 67046-0975-03 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4673 | 70518-4673-00 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-386 | 31722-0386-0131722-0386-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-384 | 31722-0384-0131722-0384-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-385 | 31722-0385-0131722-0385-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-387 | 31722-0387-0131722-0387-05 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1567 | 67046-1567-03 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1547 | 67046-1547-03 |
| Fluphenazine hydrochloride | Fluphenazine hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4273 | 70518-4273-0070518-4273-01 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-791 | 62332-0791-3162332-0791-71 |
Other NDCs under ANDA 218055
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 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-689 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-686 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 2.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-687 |