Fentanyl Citrate, Bupivacaine HCl

Manufacturer: Cantrell Drug Company
Effective date: 2014-08-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 20:19:10

Label at a glance#

ProductFentanyl Citrate, Bupivacaine HCl

Active ingredientFentanyl Citrate, BUPIVACAINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BUPIVACAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
FENTANYL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Code 128	(01)00352533080616	GTIN-14: 00352533080616 GTIN-12: 352533080616 UPC-A: 352533080616 EAN-13: 0352533080616 GTIN storage (14 digits): 00352533080616	52533-080-61.jpg
Data code	Data Matrix	01003525330806161710		52533-080-61.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
77d14d2b-b9bf-4254-8dd6-c60dedb281d3	Product name	1	20231002
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
a8df478d-5b88-9654-981b-87dff14dda8b	Product name	2	20190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57	Product name	2	20180118
bb365072-425e-ca0a-021e-fd8b78162502	Product name	2	20161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6	Product name	2	20160104
739fa0ac-b690-63c4-9904-e20dffbf78f9	Product name	1	20140508
7763fcbb-367d-ed06-b37f-e1529b6241be	Product name	1	20140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52533-080-61	2019-11-27	C162847	48780-1	9855e2a2-4e45-60a7-e053-dbdaa90a05bd	Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52533-080-61	Fentanyl Citrate, Bupivacaine HCl	250 mL in 1 BAG	INJECTION, SOLUTION	250		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52533-080	FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	8	Legacy NDC, 1 package rows	20140813_cfecc5f4-5ce0-46d5-b1d4-92654246fcb2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BUPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	7TQO7W3VT8	8
Fentanyl Citrate	ACTIVE INGREDIENT	MUN5LYG46H	8
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	8
Fentanyl	ACTIVE MOIETY	UF599785JZ	8
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	8
Water	INACTIVE INGREDIENT	059QF0KO0R	8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Fentanyl Citrate, Bupivacaine HCl
Fentanyl Citrate
Fentanyl
BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
Sodium Chloride
Water
HYDROCHLORIC ACID
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52533-080	52533-080-61

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Fentanyl Citrate	MUN5LYG46H	ACTIM
BUPIVACAINE HYDROCHLORIDE	7TQO7W3VT8	ACTIR
Sodium Chloride	451W47IQ8X	IACT
Water	059QF0KO0R	IACT
HYDROCHLORIC ACID	QTT17582CB	CNTM
SODIUM HYDROXIDE	55X04QC32I	CNTM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 134 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / RETROBULBAR		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVASCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / OPHTHALMIC	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / PARENTERAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	ENEMA / RECTAL	0.7 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVESICAL		351 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRABURSAL	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAVITARY	0.82 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INFILTRATION		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c2d97900-1e9f-46cf-b5c7-773da45f87e2			cfecc5f4-5ce0-46d5-b1d4-92654246fcb2	2014-08-13		Exact identifier spl id: c2d97900-1e9f-46cf-b5c7-773da45f87e2 spl set id: cfecc5f4-5ce0-46d5-b1d4-92654246fcb2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.