NDC 52533-080

Fentanyl Citrate, Bupivacaine HCl

Fentanyl Citrate, Bupivacaine Hcl

Fentanyl Citrate, Bupivacaine HCl is a Epidural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cantrell Drug Company. The primary component is Fentanyl Citrate; Bupivacaine Hydrochloride.

Product ID52533-080_10c0befd-7161-4f4c-9a5c-ebf2422d33aa
NDC52533-080
Product TypeHuman Prescription Drug
Proprietary NameFentanyl Citrate, Bupivacaine HCl
Generic NameFentanyl Citrate, Bupivacaine Hcl
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL
Marketing Start Date2013-09-17
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameCantrell Drug Company
Substance NameFENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE
Active Ingredient Strength2 ug/mL; mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52533-080-11

250 mL in 1 BAG (52533-080-11)
Marketing Start Date2014-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52533-080-75 [52533008075]

Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-25
Inactivation Date2020-01-31

NDC 52533-080-01 [52533008001]

Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-01
Marketing End Date2013-07-22

NDC 52533-080-64 [52533008064]

Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-17
Inactivation Date2020-01-31

NDC 52533-080-11 [52533008011]

Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-25
Inactivation Date2019-11-27

NDC 52533-080-71 [52533008071]

Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-16
Marketing End Date2013-07-22

NDC 52533-080-61 [52533008061]

Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-16
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE2 ug/mL

OpenFDA Data

SPL SET ID:17606e46-f2c4-4821-b67d-a76b41a227e1
Manufacturer
UNII

Pharmacological Class

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]
  • Amide Local Anesthetic [EPC]
  • Amides [CS]
  • Local Anesthesia [PE]

NDC Crossover Matching brand name "Fentanyl Citrate, Bupivacaine HCl" or generic name "Fentanyl Citrate, Bupivacaine Hcl"

NDCBrand NameGeneric Name
52533-080Fentanyl Citrate, Bupivacaine HClFentanyl Citrate, Bupivacaine HCl
52533-081Fentanyl Citrate, Bupivacaine HClFentanyl Citrate, Bupivacaine HCl
52533-174Fentanyl Citrate, Bupivacaine HClFentanyl Citrate, Bupivacaine HCl

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