Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 0832-6003
Fluphenazine hydrochloride 1 mg/1 · Tablet, Film coated · Oral · Upsher-Smith Laboratories,LLC
NDC codes
FDA NDC DirectoryProduct 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
- Upsher-Smith Laboratories,LLCNDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213784
- Marketing start
- Marketing end
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 0832-6003_3bb74f82-8872-9829-e063-6294a90aeaceSPL ID 3bb74f82-8872-9829-e063-6294a90aeaceSPL set ID f07bb3f1-c68c-441b-9de4-99a219f2500aRxCUI 859841, 860918, 865117, 865123UNII ZOU145W1XLUPC 0308326006110, 0308326004116
- 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.
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 0832-6003
- What is NDC 0832-6003?
- 0832-6003 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Upsher-Smith Laboratories,LLC.
- What drug is associated with this NDC?
- Fluphenazine Hydrochloride.
- What is the active ingredient?
- Fluphenazine hydrochloride.
- Who is the labeler?
- Upsher-Smith Laboratories,LLC, NDC labeler code 0832. 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?
- 99 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 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 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-386 | 31722-0386-0131722-0386-05 |
| 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 1 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-788 | 46708-0788-3146708-0788-71 |
Other NDCs under ANDA 213784
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 | Upsher-Smith Laboratories,LLC | 0832-6004 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories,LLC | 0832-6005 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories,LLC | 0832-6006 |