NDC 70069-383

HALOPERIDOL DECANOATE

Haloperidol Decanoate

HALOPERIDOL DECANOATE is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Haloperidol Decanoate.

• Product ID: 70069-383_29085961-acdf-417b-a578-0261a5e76727
• NDC: 70069-383
• Product Type: Human Prescription Drug
• Proprietary Name: HALOPERIDOL DECANOATE
• Generic Name: Haloperidol Decanoate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2019-03-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209101
• Labeler Name: Somerset Therapeutics, LLC
• Substance Name: HALOPERIDOL DECANOATE
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Typical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70069-383-01

1 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-01) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-10-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70069-383-05 [70069038305]

HALOPERIDOL DECANOATE INJECTION

• Marketing Category: ANDA
• Application Number: ANDA209101
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-04-04

NDC 70069-383-01 [70069038301]

HALOPERIDOL DECANOATE INJECTION

• Marketing Category: ANDA
• Application Number: ANDA209101
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-04-04

NDC 70069-383-10 [70069038310]

HALOPERIDOL DECANOATE INJECTION

• Marketing Category: ANDA
• Application Number: ANDA209101
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-04-04

Drug Details

Active Ingredients

Ingredient	Strength
HALOPERIDOL DECANOATE	100 mg/mL

OpenFDA Data

• SPL SET ID: f2bff27f-929f-4f7d-b3eb-084ebc2a885f
• Manufacturer:
  • Somerset Therapeutics, LLC
• UNII:
  • AC20PJ4101
• RxNorm Concept Unique ID - RxCUI:
  • 1719862
  • 1719803
• UPC Code:
  • 0370069031018
  • 0370069382011
  • 0370069384015
  • 0370069030011
  • 0370069383018
  • 0370069381014

Pharmacological Class

• Typical Antipsychotic [EPC]

NDC Crossover Matching brand name "HALOPERIDOL DECANOATE" or generic name "Haloperidol Decanoate"

NDC	Brand Name	Generic Name
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
68083-137	Haloperidol Decanoate	Haloperidol Decanoate
68083-138	Haloperidol Decanoate	Haloperidol Decanoate
70069-030	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE
70069-031	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE
70518-1809	Haloperidol Decanoate	Haloperidol Decanoate
25021-834	haloperidol decanoate	haloperidol decanoate
63323-469	Haloperidol Decanoate	Haloperidol Decanoate
63323-471	Haloperidol Decanoate	Haloperidol Decanoate
64725-0471	Haloperidol Decanoate	Haloperidol Decanoate
67457-381	Haloperidol Decanoate	Haloperidol Decanoate
67457-409	Haloperidol Decanoate	Haloperidol Decanoate
67457-410	Haloperidol Decanoate	Haloperidol Decanoate
70069-383	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE
70069-382	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE
70069-384	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE
70069-381	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE