Haloperidol Decanoate Injection

Haloperidol Decanoate Injection
SPL v1
SPL
SPL Set ID d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9
Route
INTRAMUSCULAR
Published
Effective Date 2023-09-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Haloperidol (50 mg)
Inactive Ingredients
Sesame Oil Benzyl Alcohol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-11-14
Description

50 mg/mL Carton (3 vials per carton) NDC 70771-1851-9 Haloperidol Decanoate Injection 50 mg/mL* For Intramuscular Use Only 3 X 1 mL Single-Dose Vials Sterile Rx only 250 mg/5 mL (50 mg/mL) Carton (1 vial per carton) NDC 70771-1852-1 Haloperidol Decanoate Injection 250 mg/5 mL* (50 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only 100 mg/mL Carton (1 vial per carton) NDC 70771-1853-1 Haloperidol Decanoate Injection 100 mg/mL* For Intramuscular Use Only 1 mL Single-Dose Vial Sterile Rx only 500 mg/5 mL (100 mg/mL) Carton (1 vial per carton) NDC 70771-1854-1 Haloperidol Decanoate Injection 500 mg/5 mL* (100 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only

Medication Information

Description

50 mg/mL Carton (3 vials per carton) NDC 70771-1851-9 Haloperidol Decanoate Injection 50 mg/mL* For Intramuscular Use Only 3 X 1 mL Single-Dose Vials Sterile Rx only 250 mg/5 mL (50 mg/mL) Carton (1 vial per carton) NDC 70771-1852-1 Haloperidol Decanoate Injection 250 mg/5 mL* (50 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only 100 mg/mL Carton (1 vial per carton) NDC 70771-1853-1 Haloperidol Decanoate Injection 100 mg/mL* For Intramuscular Use Only 1 mL Single-Dose Vial Sterile Rx only 500 mg/5 mL (100 mg/mL) Carton (1 vial per carton) NDC 70771-1854-1 Haloperidol Decanoate Injection 500 mg/5 mL* (100 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only

Package Label.principal Display Panel

50 mg/mL Carton (3 vials per carton)

NDC 70771-1851-9

Haloperidol Decanoate

Injection

50 mg/mL*

For Intramuscular Use Only

3 X 1 mL

Single-Dose Vials

Sterile

Rx only

250 mg/5 mL (50 mg/mL) Carton (1 vial per carton)

NDC 70771-1852-1

Haloperidol Decanoate Injection

250 mg/5 mL*

(50 mg/mL)

For Intramuscular Use Only

5 mL

Multiple-Dose Vial

Sterile

Rx only

100 mg/mL Carton (1 vial per carton)

NDC 70771-1853-1

Haloperidol Decanoate Injection

100 mg/mL*

For Intramuscular Use Only

1 mL

Single-Dose Vial

Sterile

Rx only

500 mg/5 mL (100 mg/mL) Carton (1 vial per carton)

NDC 70771-1854-1

Haloperidol Decanoate Injection

500 mg/5 mL*

(100 mg/mL)

For Intramuscular Use Only

5 mL Multiple-Dose Vial

Sterile

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

50 mg/mL Carton (3 vials per carton)

NDC 70771-1851-9

Haloperidol Decanoate

Injection

50 mg/mL*

For Intramuscular Use Only

3 X 1 mL

Single-Dose Vials

Sterile

Rx only

250 mg/5 mL (50 mg/mL) Carton (1 vial per carton)

NDC 70771-1852-1

Haloperidol Decanoate Injection

250 mg/5 mL*

(50 mg/mL)

For Intramuscular Use Only

5 mL

Multiple-Dose Vial

Sterile

Rx only

100 mg/mL Carton (1 vial per carton)

NDC 70771-1853-1

Haloperidol Decanoate Injection

100 mg/mL*

For Intramuscular Use Only

1 mL

Single-Dose Vial

Sterile

Rx only

500 mg/5 mL (100 mg/mL) Carton (1 vial per carton)

NDC 70771-1854-1

Haloperidol Decanoate Injection

500 mg/5 mL*

(100 mg/mL)

For Intramuscular Use Only

5 mL Multiple-Dose Vial

Sterile

Rx only

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:38:51.984819 · Updated: 2026-03-14T21:55:56.047430