Cisatracurium Besylate Injection

Cisatracurium Besylate Injection
SPL v3
SPL
SPL Set ID e145a40e-b046-4064-b35e-0da40ff3703e
Route
INTRAVENOUS
Published
Effective Date 2020-10-12
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cisatracurium (2 mg)
Inactive Ingredients
Benzenesulfonic Acid Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-02-12

Description

Principal Display Panel – Container Label (10 mg/5 mL) NDC 72785-0008-1 Cisatracurium Besylate Injection, USP 10 mg/5 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection Preservative free 5 mL Single-Dose Vial Rx only Zydus Pharmaceuticals Principal Display Panel – Container Label (200 mg/20 mL) NDC 72785-0009-1 Cisatracurium Besylate Injection, USP 200 mg/20 mL* (10 mg/mL) WARNING: Paralyzing Agent For ICU use only. For Intravenous Injection Preservative free 20 mL Single-Dose Vial Rx only Zydus Pharmaceuticals Principal Display Panel – Carton Label (10 mg/5 mL) NDC 72785-0008-6 Cisatracurium Besylate Injection, USP 10 mg/5 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection Preservative free 10 x 5 mL Single-Dose Vials Rx only Zydus Pharmaceuticals Principal Display Panel – Carton Label (200 mg/20 mL) NDC 72785-0009-6 Cisatracurium Besylate Injection, USP 200 mg/20 mL* (10 mg/mL) WARNING: Paralyzing Agent For ICU use only. For Intravenous Injection Preservative free 10 x 20 mL Single-Dose Vials Rx only Zydus Pharmaceuticals


Medication Information

Description

Principal Display Panel – Container Label (10 mg/5 mL) NDC 72785-0008-1 Cisatracurium Besylate Injection, USP 10 mg/5 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection Preservative free 5 mL Single-Dose Vial Rx only Zydus Pharmaceuticals Principal Display Panel – Container Label (200 mg/20 mL) NDC 72785-0009-1 Cisatracurium Besylate Injection, USP 200 mg/20 mL* (10 mg/mL) WARNING: Paralyzing Agent For ICU use only. For Intravenous Injection Preservative free 20 mL Single-Dose Vial Rx only Zydus Pharmaceuticals Principal Display Panel – Carton Label (10 mg/5 mL) NDC 72785-0008-6 Cisatracurium Besylate Injection, USP 10 mg/5 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection Preservative free 10 x 5 mL Single-Dose Vials Rx only Zydus Pharmaceuticals Principal Display Panel – Carton Label (200 mg/20 mL) NDC 72785-0009-6 Cisatracurium Besylate Injection, USP 200 mg/20 mL* (10 mg/mL) WARNING: Paralyzing Agent For ICU use only. For Intravenous Injection Preservative free 10 x 20 mL Single-Dose Vials Rx only Zydus Pharmaceuticals

Section 51945-4

Principal Display Panel – Container Label (10 mg/5 mL)

NDC 72785-0008-1

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

5 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Container Label (200 mg/20 mL)

NDC 72785-0009-1

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

20 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Carton Label (10 mg/5 mL)

NDC 72785-0008-6

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

10 x 5 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Carton Label (200 mg/20 mL)

NDC 72785-0009-6

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

10 x 20 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals


Structured Label Content

Section 51945-4 (51945-4)

Principal Display Panel – Container Label (10 mg/5 mL)

NDC 72785-0008-1

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

5 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Container Label (200 mg/20 mL)

NDC 72785-0009-1

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

20 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Carton Label (10 mg/5 mL)

NDC 72785-0008-6

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

10 x 5 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Carton Label (200 mg/20 mL)

NDC 72785-0009-6

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

10 x 20 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals


Advanced Ingredient Data


Raw Label Data

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