What is NDC 0121-0581?

0121-0581 is the product NDC for Haloperidol, Haloperidol 2 mg/mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 3 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 Haloperidol?

170 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Haloperidol NDC 0121-0581 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0581Add 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
0121-0581-04	0012105810400121058104	120 mL in 1 BOTTLE (0121-0581-04)Marketed from Nov 10, 2009
0121-0581-05	0012105810500121058105	10 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSEMarketed from Nov 10, 2009
0121-0581-15	0012105811500121058115	15 mL in 1 BOTTLE (0121-0581-15)Marketed from Jun 12, 2020

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): Haloperidol
Generic name (nonproprietary): haloperidol
Active ingredients: Haloperidol — 2 mg/mL
Dosage form: Solution
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 073037
Marketing start: Nov 10, 2009
Listing expires: Dec 31, 2026
Identifiers: Product ID 0121-0581_0f6d8b89-8c33-4459-84af-e588eb27587cSPL ID 0f6d8b89-8c33-4459-84af-e588eb27587cSPL set ID b488c106-f1ee-4b7b-8516-01162fb929f7RxCUI 141935UNII J6292F8L3DUPC 0301210581045, 0301210581151
Pharmacologic class: Typical Antipsychotic

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

N400121058104 followed by a unit qualifier and the quantity

Package 00121-0581-04. 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 Jan 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Haloperidol oral solution is indicated for use in the management of manifestations of psychotic disorders. Haloperidol oral solution is indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol oral solution is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining att…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0581

What is NDC 0121-0581?: 0121-0581 is the product NDC for Haloperidol, Haloperidol 2 mg/mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Haloperidol.
What is the active ingredient?: Haloperidol.
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 Haloperidol?: 170 other product NDCs are listed under this name. See all Haloperidol 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 Haloperidol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Haloperidol	Haloperidol .5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-264	27241-0264-01
Haloperidol	Haloperidol 1 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-265	27241-0265-01
Haloperidol	Haloperidol 2 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-266	27241-0266-01
Haloperidol	Haloperidol 5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-267	27241-0267-01
Haloperidol	Haloperidol 10 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-268	27241-0268-01
Haloperidol	Haloperidol 20 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-269	27241-0269-01
Haloperidol	Haloperidol 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4725	70518-4725-00
Haloperidol	Haloperidol 5 mg/1	TabletOral	Coupler LLC	67046-0329	67046-0329-03
Haloperidol	Haloperidol 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-037	87441-0037-01
Haloperidol	Haloperidol .5 mg/1	TabletOral	Safecor Health, LLC	48433-151	48433-0151-20

All 171 Haloperidol NDCs

Other NDCs under ANDA 073037

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

FDA NDC Directory listings under ANDA 073037
Product	Strength	Form · route	Labeler	Product NDC
Haloperidol	Haloperidol 2 mg/mL	SolutionOral	American Health Packaging	60687-799