Prescription drug · ANDA
Haloperidol Lactate NDC 55154-7076
Haloperidol lactate 5 mg/mL · Injection, Solution · Intramuscular · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-7076-5 | 5515470760555154707605 | 5 VIAL in 1 BAG (55154-7076-5) / 1 mL in 1 VIALMarketed from May 10, 2011 |
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
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078347
- Marketing start
- Listing expires
- Identifiers
- Product ID 55154-7076_00d07c9b-553f-4b13-a055-fb2606c538d7SPL ID 00d07c9b-553f-4b13-a055-fb2606c538d7SPL set ID 7d1a9689-23c8-44ef-a474-8c607e13d794RxCUI 1719646UNII 6387S86PK3UPC 0055154707657
- 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
N455154707605followed by a unit qualifier and the quantityPackage 55154-7076-05. 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.
About NDC 55154-7076
- What is NDC 55154-7076?
- 55154-7076 is the product NDC for Haloperidol Lactate, Haloperidol lactate 5 mg/mL injection, solution, listed with the FDA by Cardinal Health 107, LLC. 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 Lactatehaloperidol | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Henry Schein, Inc. | 0404-9871 | 00404-9871-01 |
| 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 |
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 Lactatehaloperidol | Haloperidol lactate 5 mg/mL | Injection, SolutionIntramuscular | Henry Schein, Inc. | 0404-9871 |
| 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 |