Prescription drug · ANDA
Fluphenazine Hydrochloride NDC 68462-337
Fluphenazine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-337-01 | 6846203370168462033701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-01)Marketed from Nov 6, 2023 | |
| 68462-337-05 | 6846203370568462033705 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-05)Marketed from Nov 6, 2023 | |
| 68462-337-14 | 6846203371468462033714 | 100 BLISTER PACK in 1 CARTON (68462-337-14) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 6, 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, Film coated
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216350
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 68462-337_b5186569-6be5-4ff2-a95e-f162f76254d9SPL ID b5186569-6be5-4ff2-a95e-f162f76254d9SPL set ID 4c3eea71-a7a1-4eda-9871-034ddeb83ed6RxCUI 859841, 860918, 865117, 865123UNII ZOU145W1XLUPC 0368462338018, 0368462337011, 0368462914014, 0368462336014
- 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
N468462033701followed by a unit qualifier and the quantityPackage 68462-0337-01. 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 68462-337
- What is NDC 68462-337?
- 68462-337 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 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?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 216350
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 | Glenmark Pharmaceuticals Inc., USA | 68462-336 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-338 |
| Fluphenazine Hydrochloride | Fluphenazine hydrochloride 1 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-914 |