What is NDC 54838-501?

54838-501 is the product NDC for Haloperidol, Haloperidol lactate 2 mg/mL solution, 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 54838. 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 54838-501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54838-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54838-0501Add 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
54838-501-15	5483805011554838050115	15 mL in 1 BOTTLE, DROPPER (54838-501-15)Marketed from Sep 28, 1993
54838-501-40	5483805014054838050140	120 mL in 1 BOTTLE, DROPPER (54838-501-40)Marketed from Sep 28, 1993

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): Haloperidol
Generic name (nonproprietary): haloperidol
Active ingredients: Haloperidol lactate — 2 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 54838
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073364
Marketing start: Sep 28, 1993
Listing expires: Dec 31, 2026
Identifiers: Product ID 54838-501_898ee841-bdf7-4306-ac5c-282e522afd9fSPL ID 898ee841-bdf7-4306-ac5c-282e522afd9fSPL set ID 3e44fed0-6132-4881-a9cd-af6156c7af9cRxCUI 141935UNII 6387S86PK3UPC 0354838501407
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

N454838050115 followed by a unit qualifier and the quantity

Package 54838-0501-15. 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 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 54838-501

What is NDC 54838-501?: 54838-501 is the product NDC for Haloperidol, Haloperidol lactate 2 mg/mL solution, 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?: Haloperidol.
What is the active ingredient?: Haloperidol lactate.
Who is the labeler?: Lannett Company, Inc., NDC labeler code 54838. 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