NDC 52584-426

Haloperidol Lactate

Haloperidol

Haloperidol Lactate is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Haloperidol Lactate.

• Product ID: 52584-426_09436da9-2e66-4fca-a8bc-6add5da4f39e
• NDC: 52584-426
• Product Type: Human Prescription Drug
• Proprietary Name: Haloperidol Lactate
• Generic Name: Haloperidol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2015-10-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078347
• Labeler Name: General Injectables and Vaccines, Inc.
• Substance Name: HALOPERIDOL LACTATE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Typical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52584-426-00

1 VIAL in 1 BAG (52584-426-00) > 1 mL in 1 VIAL

• Marketing Start Date: 2018-08-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-426-00 [52584042600]

Haloperidol Lactate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078347
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-24

Drug Details

Active Ingredients

Ingredient	Strength
HALOPERIDOL LACTATE	5 mg/mL

OpenFDA Data

• SPL SET ID: 1a7d3180-5d2a-496b-8c82-b82ce6d70e10
• Manufacturer:
  • General Injectables and Vaccines, Inc.
• UNII:
  • 6387S86PK3
• RxNorm Concept Unique ID - RxCUI:
  • 1719646

Pharmacological Class

• Typical Antipsychotic [EPC]
• Typical Antipsychotic [EPC]

NDC Crossover Matching brand name "Haloperidol Lactate" or generic name "Haloperidol"

NDC	Brand Name	Generic Name
70518-1053	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE
52584-426	Haloperidol Lactate	Haloperidol Lactate
55154-7076	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE
67457-426	HALOPERIDOL LACTATE	HALOPERIDOL LACTATE
0093-9604	Haloperidol	Haloperidol lactate
0121-0581	Haloperidol	Haloperidol
0143-9319	Haloperidol	Haloperidol lactate
0143-9501	Haloperidol	Haloperidol lactate
0143-9502	Haloperidol	Haloperidol Lactate
0378-0214	Haloperidol	haloperidol
0378-0257	Haloperidol	haloperidol
0378-0327	Haloperidol	haloperidol
0378-0334	Haloperidol	haloperidol
0378-0335	Haloperidol	haloperidol
0378-0351	Haloperidol	haloperidol