NDC codes

FDA NDC Directory
Product NDC (as listed)70518-1053Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-1053Add 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
70518-1053-0705181053007051810530025 VIAL in 1 CARTON (70518-1053-0) / 1 mL in 1 VIAL (70518-1053-1)Marketed from Mar 7, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Lactate
Generic name (nonproprietary)
haloperidol lactate
Active ingredients
Haloperidol lactate — 5 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078347
Marketing start
Listing expires
Identifiers
Product ID 70518-1053_5691b7c8-84a0-430f-e063-6394a90a35b6SPL ID 5691b7c8-84a0-430f-e063-6394a90a35b6SPL set ID 4289f7db-e25d-4578-8adf-f0222ae64aa6RxCUI 1719646UNII 6387S86PK3
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N470518105300 followed by a unit qualifier and the quantity

Package 70518-1053-00. 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 injection is indicated for the treatment of patients with schizophrenia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-1053

What is NDC 70518-1053?
70518-1053 is the product NDC for Haloperidol Lactate, Haloperidol lactate 5 mg/mL injection, solution, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Haloperidol Lactate.
What is the active ingredient?
Haloperidol lactate.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. 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 Lactate?
3 other product NDCs are listed under this name. See all Haloperidol Lactate 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 Lactate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Haloperidol LactatehaloperidolHaloperidol lactate 5 mg/mLInjection, SolutionIntramuscularHenry Schein, Inc.0404-987100404-9871-01
Haloperidol LactateHaloperidol lactate 5 mg/mLInjection, SolutionIntramuscularMylan Institutional LLC67457-42667457-0426-12
Haloperidol LactateHaloperidol lactate 5 mg/mLInjection, SolutionIntramuscularCardinal Health 107, LLC55154-707655154-7076-05

Other NDCs under ANDA 078347

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

FDA NDC Directory listings under ANDA 078347
ProductStrengthForm · routeLabelerProduct NDC
Haloperidol LactatehaloperidolHaloperidol lactate 5 mg/mLInjection, SolutionIntramuscularHenry Schein, Inc.0404-9871
Haloperidol LactateHaloperidol lactate 5 mg/mLInjection, SolutionIntramuscularCardinal Health 107, LLC55154-7076
Haloperidol LactateHaloperidol lactate 5 mg/mLInjection, SolutionIntramuscularMylan Institutional LLC67457-426

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in