NDC 52584-042

Bupivacaine Hydrochloride and Epinephrine

Bupivacaine Hydrochloride And Epinephrine

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

• Product ID: 52584-042_799eebf4-53cc-404f-bd27-9857b2471cb3
• NDC: 52584-042
• Product Type: Human Prescription Drug
• Proprietary Name: Bupivacaine Hydrochloride and Epinephrine
• Generic Name: Bupivacaine Hydrochloride And Epinephrine
• Dosage Form: Injection, Solution
• Route of Administration: EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
• Marketing Start Date: 2010-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA071165
• Labeler Name: General Injectables & Vaccines, 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: 2022-12-31

Packaging

NDC 52584-042-17

1 VIAL, SINGLE-DOSE in 1 BAG (52584-042-17) > 30 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2016-09-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-042-02 [52584004202]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA071165
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-07-01
• Marketing End Date: 2017-01-16

NDC 52584-042-17 [52584004217]

Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA071165
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-22

Drug Details

Active Ingredients

Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	2.5 mg/mL

OpenFDA Data

• SPL SET ID: fab28f67-9dfa-4bf7-8758-c0c4b6aef56a
• Manufacturer:
  • General Injectables & Vaccines, Inc
• UNII:
  • 7TQO7W3VT8
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1012377

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]
• 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