Prescription drug · ANDA
Haloperidol Lactate (Haloperidol) NDC 0404-9871
Haloperidol lactate 5 mg/mL · Injection, Solution · Intramuscular · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9871-01 | 0040498710100404987101 | 1 VIAL in 1 BAG (0404-9871-01) / 1 mL in 1 VIALMarketed from Jan 11, 2022 |
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 Lactate
- Generic name (nonproprietary)
- haloperidol
- Active ingredients
- Haloperidol lactate — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078347
- Marketing start
- Listing expires
- Identifiers
- Product ID 0404-9871_74d33642-a53d-4042-aa8f-87460d97fd9fSPL ID 74d33642-a53d-4042-aa8f-87460d97fd9fSPL set ID 65df5d2d-79aa-41d4-866a-566e520320f7RxCUI 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.
- NDC on a medical claim
N400404987101followed by a unit qualifier and the quantityPackage 00404-9871-01. 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 Injection, USP is indicated for use in the treatment of schizophrenia.
Excerpt only. Read the full label for complete information.
About NDC 0404-9871
- What is NDC 0404-9871?
- 0404-9871 is the product NDC for Haloperidol Lactate (haloperidol), Haloperidol lactate 5 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Haloperidol Lactate (Haloperidol).
- What is the active ingredient?
- Haloperidol lactate.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. 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.
Related NDCs: other Haloperidol Lactate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Haloperidol Lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | REMEDYREPACK INC. | 70518-1053 | 70518-1053-00 |
| Haloperidol Lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Mylan Institutional LLC | 67457-426 | 67457-0426-12 |
| Haloperidol Lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Cardinal Health 107, LLC | 55154-7076 | 55154-7076-05 |
Other NDCs under ANDA 078347
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Haloperidol Lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Cardinal Health 107, LLC | 55154-7076 |
| Haloperidol Lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Mylan Institutional LLC | 67457-426 |
| Haloperidol Lactate | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | REMEDYREPACK INC. | 70518-1053 |