NDC 68083-138

Haloperidol Decanoate

Haloperidol Decanoate

Haloperidol Decanoate is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Haloperidol Decanoate.

• Product ID: 68083-138_c10c795a-0eb8-4586-8444-0db27088fef2
• NDC: 68083-138
• Product Type: Human Prescription Drug
• Proprietary Name: Haloperidol Decanoate
• Generic Name: Haloperidol Decanoate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2017-01-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205241
• Labeler Name: Gland Pharma Limited
• Substance Name: HALOPERIDOL DECANOATE
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Typical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68083-138-02

1 VIAL in 1 CARTON (68083-138-02) > 5 mL in 1 VIAL

• Marketing Start Date: 2017-01-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-138-01 [68083013801]

Haloperidol Decanoate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA205241
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-16

NDC 68083-138-10 [68083013810]

Haloperidol Decanoate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA205241
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-16

NDC 68083-138-02 [68083013802]

Haloperidol Decanoate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA205241
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-16

Drug Details

Active Ingredients

Ingredient	Strength
HALOPERIDOL DECANOATE	100 mg/mL

OpenFDA Data

• SPL SET ID: 1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • AC20PJ4101
• RxNorm Concept Unique ID - RxCUI:
  • 859867
  • 859871
  • 1719862
  • 1719803

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