NDC 50458-253

Haldol Decanoate

Haloperidol Decanoate

Haldol Decanoate is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Haloperidol Decanoate.

• Product ID: 50458-253_3f73424e-67ec-11e9-b071-92e20099106d
• NDC: 50458-253
• Product Type: Human Prescription Drug
• Proprietary Name: Haldol Decanoate
• Generic Name: Haloperidol Decanoate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 1986-01-14
• Marketing Category: NDA / NDA
• Application Number: NDA018701
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: HALOPERIDOL DECANOATE
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Typical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50458-253-03

3 AMPULE in 1 BOX (50458-253-03) > 1 mL in 1 AMPULE

• Marketing Start Date: 1986-01-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-253-03 [50458025303]

Haldol Decanoate INJECTION

• Marketing Category: NDA
• Application Number: NDA018701
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1986-01-14

NDC 50458-253-01 [50458025301]

Haldol Decanoate INJECTION

• Marketing Category: NDA
• Application Number: NDA018701
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1986-01-14
• Marketing End Date: 1986-01-15

Drug Details

Active Ingredients

Ingredient	Strength
HALOPERIDOL DECANOATE	50 mg/mL

OpenFDA Data

• SPL SET ID: af0159a8-dff5-449a-aa2b-a0c430081e21
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • AC20PJ4101
• RxNorm Concept Unique ID - RxCUI:
  • 1720026
  • 1719847
  • 1719803
  • 1719862
• UPC Code:
  • 0350458253030
  • 0350458254143

Pharmacological Class

• Typical Antipsychotic [EPC]

NDC Crossover Matching brand name "Haldol Decanoate" or generic name "Haloperidol Decanoate"

NDC	Brand Name	Generic Name
50458-254	Haldol Decanoate	Haldol Decanoate
50458-253	Haldol Decanoate	Haldol Decanoate
0143-9295	Haloperidol Decanoate	Haloperidol Decanoate
0143-9296	Haloperidol Decanoate	Haloperidol Decanoate
0703-7011	Haloperidol Decanoate	Haloperidol Decanoate
0703-7013	Haloperidol Decanoate	Haloperidol Decanoate
0703-7021	Haloperidol Decanoate	Haloperidol Decanoate
0703-7023	Haloperidol Decanoate	Haloperidol Decanoate
0703-7121	Haloperidol Decanoate	Haloperidol Decanoate
0703-7123	Haloperidol Decanoate	Haloperidol Decanoate
0703-7131	Haloperidol Decanoate	Haloperidol Decanoate
0703-7133	Haloperidol Decanoate	Haloperidol Decanoate
10147-0921	Haloperidol Decanoate	Haloperidol Decanoate
10147-0922	Haloperidol Decanoate	Haloperidol Decanoate
25021-831	haloperidol decanoate	haloperidol decanoate
25021-833	haloperidol decanoate	haloperidol decanoate