What is NDC 0527-1791?

0527-1791 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluphenazine Hydrochloride NDC 0527-1791

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1791Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1791Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0527-1791-01	0052717910100527179101	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1791-01)Marketed from Aug 25, 1988
0527-1791-05	0052717910500527179105	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1791-05)Marketed from Aug 25, 1988

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089743
Marketing start: Aug 25, 1988
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 0527-1791_59cf1ea7-b827-4780-bf94-cd3446d6dcc3SPL ID 59cf1ea7-b827-4780-bf94-cd3446d6dcc3SPL set ID 6cd6ba35-3481-48c1-87db-dc74ce9d7d75RxCUI 859841, 860918, 865117, 865123UNII ZOU145W1XLUPC 0305271791016, 0305271790019, 0305271789013
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

N400527179101 followed by a unit qualifier and the quantity

Package 00527-1791-01. 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 Nov 13, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 0527-1791

What is NDC 0527-1791?: 0527-1791 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Lannett Company, Inc.. 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?: Lannett Company, Inc., NDC labeler code 0527. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluphenazine Hydrochloride NDCs
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

All 100 Fluphenazine Hydrochloride NDCs

Other NDCs under ANDA 089743

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 089743
Product	Strength	Form · route	Labeler	Product NDC
Fluphenazine Hydrochloride	Fluphenazine hydrochloride 1 mg/1	Tablet, Film coatedOral	Lannett Company, Inc.	0527-1788
Fluphenazine Hydrochloride	Fluphenazine hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Lannett Company, Inc.	0527-1789
Fluphenazine Hydrochloride	Fluphenazine hydrochloride 5 mg/1	Tablet, Film coatedOral	Lannett Company, Inc.	0527-1790
Fluphenazine Hydrochloride	Fluphenazine hydrochloride 1 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7157
Fluphenazine Hydrochloride	Fluphenazine hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7158
Fluphenazine Hydrochloride	Fluphenazine hydrochloride 5 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7159
Fluphenazine Hydrochloride	Fluphenazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7160