NDC 0264-9379

Bupivacaine Hydrochloride with Dextrose

Bupivacaine Hydrochloride With Dextrose

Bupivacaine Hydrochloride with Dextrose is a Subarachnoid Injection in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Bupivacaine Hydrochloride.

• Product ID: 0264-9379_0eb562f2-577f-4138-b0a7-c64c6624aefe
• NDC: 0264-9379
• Product Type: Human Prescription Drug
• Proprietary Name: Bupivacaine Hydrochloride with Dextrose
• Generic Name: Bupivacaine Hydrochloride With Dextrose
• Dosage Form: Injection
• Route of Administration: SUBARACHNOID
• Marketing Start Date: 2019-04-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209087
• Labeler Name: B. Braun Medical Inc.
• Substance Name: BUPIVACAINE HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/mL
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0264-9379-88

10 AMPULE in 1 CARTON (0264-9379-88) > 2 mL in 1 AMPULE

• Marketing Start Date: 2019-04-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0264-9379-88 [00264937988]

Bupivacaine Hydrochloride with Dextrose INJECTION

• Marketing Category: ANDA
• Application Number: ANDA209087
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-02

Drug Details

Active Ingredients

Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	7.5 mg/mL

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Local Anesthesia [PE]
• Amide Local Anesthetic [EPC]
• Amides [CS]
• Local Anesthesia [PE]