NDC codes

FDA NDC Directory
Product NDC (as listed)69292-588Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69292-0588Add 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 NDC11-digit (billing)PackageCopy
69292-588-016929205880169292058801100 TABLET in 1 BOTTLE (69292-588-01)Marketed from Apr 18, 2022

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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Amici Pharmaceuticals, LLCNDC labeler code 69292
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071173
Marketing start
Listing expires
Identifiers
Product ID 69292-588_8c9cdd3d-9751-404a-9ceb-276e8dfa6391SPL ID 8c9cdd3d-9751-404a-9ceb-276e8dfa6391SPL set ID 9a9e20dd-646a-4fe9-a345-1b5bda8e7775RxCUI 197754, 310670, 310671, 310672, 314034, 314035UNII J6292F8L3DUPC 0369292586013, 0369292582015, 0369292590010, 0369292584019, 0369292588017, 0369292580011, 0369292586105
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

N469292058801 followed by a unit qualifier and the quantity

Package 69292-0588-01. 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 . 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 69292-588

What is NDC 69292-588?
69292-588 is the product NDC for Haloperidol, Haloperidol 10 mg/1 tablet, listed with the FDA by Amici Pharmaceuticals, LLC. It has 1 package NDC, 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?
Amici Pharmaceuticals, LLC, NDC labeler code 69292. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
HaloperidolHaloperidol .5 mg/1TabletOralAjanta Pharma USA Inc.27241-26427241-0264-01
HaloperidolHaloperidol 1 mg/1TabletOralAjanta Pharma USA Inc.27241-26527241-0265-01
HaloperidolHaloperidol 2 mg/1TabletOralAjanta Pharma USA Inc.27241-26627241-0266-01
HaloperidolHaloperidol 5 mg/1TabletOralAjanta Pharma USA Inc.27241-26727241-0267-01
HaloperidolHaloperidol 10 mg/1TabletOralAjanta Pharma USA Inc.27241-26827241-0268-01
HaloperidolHaloperidol 20 mg/1TabletOralAjanta Pharma USA Inc.27241-26927241-0269-01
HaloperidolHaloperidol 10 mg/1TabletOralREMEDYREPACK INC.70518-472570518-4725-00
HaloperidolHaloperidol 5 mg/1TabletOralCoupler LLC67046-032967046-0329-03
HaloperidolHaloperidol 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-03787441-0037-01
HaloperidolHaloperidol .5 mg/1TabletOralSafecor Health, LLC48433-15148433-0151-20

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
ProductStrengthForm · routeLabelerProduct NDC
HaloperidolHaloperidol .5 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-752
HaloperidolHaloperidol 1 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-753
HaloperidolHaloperidol 2 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-754
HaloperidolHaloperidol 5 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-755
HaloperidolHaloperidol 10 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-756
HaloperidolHaloperidol 20 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-757
HaloperidolHaloperidol .5 mg/1TabletOralMethod Pharmaceuticals, LLC58657-700
HaloperidolHaloperidol 1 mg/1TabletOralMethod Pharmaceuticals, LLC58657-701
HaloperidolHaloperidol 2 mg/1TabletOralMethod Pharmaceuticals, LLC58657-702
HaloperidolHaloperidol 5 mg/1TabletOralMethod Pharmaceuticals, LLC58657-703
HaloperidolHaloperidol 10 mg/1TabletOralMethod Pharmaceuticals, LLC58657-704
HaloperidolHaloperidol 20 mg/1TabletOralMethod Pharmaceuticals, LLC58657-705
HaloperidolHaloperidol .5 mg/1TabletOralMethod Pharmaceuticals, LLC58657-900
HaloperidolHaloperidol 1 mg/1TabletOralMethod Pharmaceuticals, LLC58657-901
HaloperidolHaloperidol 2 mg/1TabletOralMethod Pharmaceuticals, LLC58657-902
HaloperidolHaloperidol 5 mg/1TabletOralMethod Pharmaceuticals, LLC58657-903
HaloperidolHaloperidol 10 mg/1TabletOralMethod Pharmaceuticals, LLC58657-904
HaloperidolHaloperidol 20 mg/1TabletOralMethod Pharmaceuticals, LLC58657-905
HaloperidolHaloperidol 10 mg/1TabletOralBryant Ranch Prepack63629-2326
HaloperidolHaloperidol .5 mg/1TabletOralBryant Ranch Prepack63629-9270

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