What is NDC 58657-905?

58657-905 is the product NDC for Haloperidol, Haloperidol 20 mg/1 tablet, listed with the FDA by Method Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Method Pharmaceuticals, LLC, NDC labeler code 58657. 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 58657-905 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58657-905Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58657-0905Add 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
58657-905-01	5865709050158657090501	100 TABLET in 1 CARTON (58657-905-01)Marketed from Jun 5, 2025
58657-905-03	5865709050358657090503	30 TABLET in 1 CARTON (58657-905-03)Marketed from Jun 5, 2025

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 — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Method Pharmaceuticals, LLCNDC labeler code 58657
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071173
Marketing start: Jun 5, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 58657-905_38c21c0c-f6b3-adda-e063-6294a90a0ffdSPL ID 38c21c0c-f6b3-adda-e063-6294a90a0ffdSPL set ID 87f8773b-bf89-4f7e-bff4-8cad117d5776RxCUI 197754, 310670, 310671, 310672, 314034, 314035UNII J6292F8L3DUPC 0358657701109, 0358657702106, 0358657704018, 0358657700010, 0358657703011, 0358657702014, 0358657705015, 0358657700102, 0358657705107, 0358657905033, 0358657704100, 0358657701017, 0358657703103
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

N458657090501 followed by a unit qualifier and the quantity

Package 58657-0905-01. 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 Jun 29, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58657-905

What is NDC 58657-905?: 58657-905 is the product NDC for Haloperidol, Haloperidol 20 mg/1 tablet, listed with the FDA by Method Pharmaceuticals, LLC. 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.
Who is the labeler?: Method Pharmaceuticals, LLC, NDC labeler code 58657. 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 071173

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

FDA NDC Directory listings under ANDA 071173
Product	Strength	Form · route	Labeler	Product NDC
Haloperidol	Haloperidol .5 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-752
Haloperidol	Haloperidol 1 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-753
Haloperidol	Haloperidol 2 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-754
Haloperidol	Haloperidol 5 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-755
Haloperidol	Haloperidol 10 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-756
Haloperidol	Haloperidol 20 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-757
Haloperidol	Haloperidol .5 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-700
Haloperidol	Haloperidol 1 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-701
Haloperidol	Haloperidol 2 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-702
Haloperidol	Haloperidol 5 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-703
Haloperidol	Haloperidol 10 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-704
Haloperidol	Haloperidol 20 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-705
Haloperidol	Haloperidol .5 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-900
Haloperidol	Haloperidol 1 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-901
Haloperidol	Haloperidol 2 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-902
Haloperidol	Haloperidol 5 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-903
Haloperidol	Haloperidol 10 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-904
Haloperidol	Haloperidol 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-2326
Haloperidol	Haloperidol .5 mg/1	TabletOral	Bryant Ranch Prepack	63629-9270
Haloperidol	Haloperidol 1 mg/1	TabletOral	Bryant Ranch Prepack	63629-9271

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