NDC 0409-9043

Bupivacaine Hydrochloride and Epinephrine

Bupivacaine Hydrochloride And Epinephrine

Bupivacaine Hydrochloride and Epinephrine is a Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.

• Product ID: 0409-9043_22d17a49-609f-4c2b-aaf0-f0ab712529ba
• NDC: 0409-9043
• Product Type: Human Prescription Drug
• Proprietary Name: Bupivacaine Hydrochloride and Epinephrine
• Generic Name: Bupivacaine Hydrochloride And Epinephrine
• Dosage Form: Injection, Solution
• Route of Administration: INFILTRATION; PERINEURAL
• Marketing Start Date: 2005-11-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA071167
• Labeler Name: Hospira, Inc.
• Substance Name: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 3 mg/mL; ug/mL
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0409-9043-01

25 CARTON in 1 BOX (0409-9043-01) > 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9043-11) > 50 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2005-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-9043-01 [00409904301]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA071167
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-11-29

NDC 0409-9043-11 [00409904311]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA071167
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-08-05

Drug Details

Active Ingredients

Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	2.5 mg/mL

OpenFDA Data

• SPL SET ID: 02a845c3-4521-4926-e397-25ab536e7cf6
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 7TQO7W3VT8
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1867596
  • 1672919
  • 1867594
  • 1012404
  • 1672917
  • 1724880
  • 1012377
  • 1725082
  • 1724884
  • 1012396
  • 1724786
  • 1724787
  • 1012384
  • 1725078

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Local Anesthesia [PE]
• Adrenergic alpha-Agonists [MoA]
• Adrenergic beta-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• beta-Adrenergic Agonist [EPC]
• Catecholamine [EPC]
• Catecholamines [CS]

NDC Crossover Matching brand name "Bupivacaine Hydrochloride and Epinephrine" or generic name "Bupivacaine Hydrochloride And Epinephrine"

NDC	Brand Name	Generic Name
0404-9828	Bupivacaine Hydrochloride and Epinephrine	Bupivacaine Hydrochloride and Epinephrine
0409-9042	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride and epinephrine
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-9045	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-9046	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
52584-042	Bupivacaine Hydrochloride and Epinephrine	Bupivacaine Hydrochloride and Epinephrine
0409-1541	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-3812	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-4208	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-5738	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-6581	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
0409-8126	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE