What is NDC 0121-0654?

0121-0654 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride .5 mg/mL elixir, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 0121-0654

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0654Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0654Add 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
0121-0654-02	00121065402	60 mL in 1 BOTTLE (0121-0654-02)Marketed from Aug 31, 2010
0121-0654-16	00121065416	473 mL in 1 BOTTLE (0121-0654-16)Marketed from Aug 31, 2010

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 — .5 mg/mL
Dosage form: Elixir
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040146
Marketing start: Aug 31, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 0121-0654_be2cdaa4-74b5-4256-90c0-e1410973b3f5SPL ID be2cdaa4-74b5-4256-90c0-e1410973b3f5SPL set ID f0a89d5d-01db-47f3-a873-33ab49c6e4f8RxCUI 859835UNII ZOU145W1XLUPC 0301210654022
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

N400121065402 followed by a unit qualifier and the quantity

Package 00121-0654-02. 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 Feb 7, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluphenazine hydrochloride elixir is 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 0121-0654

What is NDC 0121-0654?: 0121-0654 is the product NDC for Fluphenazine Hydrochloride, Fluphenazine hydrochloride .5 mg/mL elixir, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. 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?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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