Fentanyl Citrate, Bupivacaine HCl

Product NDC
52533-080
11-digit product format
525330080
Labeler code
52533
Product ID
52533-080_f3254ff6-b17a-4687-b8c2-3bff073b440e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate, Bupivacaine HCl
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL
Labeler
Cantrell Drug Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-03-25
Marketing end
0000-00-00
Substance
FENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE
Active strength
2 ug/mL; mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 12 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52533-080IInactivated by FDA2026-10-05
excluded productproduct52533-080IInactivated by FDA2026-10-05
excluded productproduct52533-080DDiscontinued by firm2026-10-05
excluded productproduct52533-080IInactivated by FDA2026-10-05
excluded productproduct52533-080DDiscontinued by firm2026-10-05
excluded productproduct52533-080IInactivated by FDA2026-10-05
excluded packagepackage52533-08052533-080-64IInactivated by FDA2026-10-05
excluded packagepackage52533-08052533-080-11IInactivated by FDA2026-10-05
excluded packagepackage52533-08052533-080-01DDiscontinued by firm2026-10-05
excluded packagepackage52533-08052533-080-61IInactivated by FDA2026-10-05
excluded packagepackage52533-08052533-080-71DDiscontinued by firm2026-10-05
excluded packagepackage52533-08052533-080-75IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 4 · 224 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52533-080-71DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52533-080-64IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52533-080-75IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52533-080-11IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52533-080-61IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52533-080-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52533-080-71DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52533-080-64IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52533-080-75IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52533-080-11IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52533-080-61IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52533-080-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52533-080-71DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52533-080-64IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52533-080-75IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52533-080-11IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52533-080-61IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52533-080-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52533-080-71DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52533-080-64IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52533-080-75IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52533-080-11IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52533-080-61IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52533-080-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52533-080-71DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52533-080-64IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52533-080-75IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52533-080-11IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52533-080-61IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52533-080-01DDiscontinued by firmcfe11265f3b6…090c488252e2…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52533-080-61Fentanyl Citrate, Bupivacaine HCl250 mL in 1 BAGINJECTION, SOLUTION2508
52533-080-75Fentanyl Citrate, Bupivacaine HCl100 mL in 1 BAGINJECTION, SOLUTION1005
52533-080-11Fentanyl Citrate, Bupivacaine HCl250 mL in 1 BAGINJECTION, SOLUTION2503
52533-080-64Fentanyl Citrate, Bupivacaine HCl125 mL in 1 BAGINJECTION, SOLUTION1252

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]8
Fentanyl CitrateACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]8
BUPIVACAINEACTIVE MOIETYY8335394ROFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]8
FentanylACTIVE MOIETYUF599785JZFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]8
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]8
WaterINACTIVE INGREDIENT059QF0KO0RFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]8
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
Fentanyl CitrateACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
BUPIVACAINEACTIVE MOIETYY8335394ROFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
FentanylACTIVE MOIETYUF599785JZFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
WaterINACTIVE INGREDIENT059QF0KO0RFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3
Fentanyl CitrateACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3
BUPIVACAINEACTIVE MOIETYY8335394ROFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3
FentanylACTIVE MOIETYUF599785JZFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]2
Fentanyl CitrateACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]2
BUPIVACAINEACTIVE MOIETYY8335394ROFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]2
FentanylACTIVE MOIETYUF599785JZFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]2
WaterINACTIVE INGREDIENT059QF0KO0RFENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52533-080FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]8Legacy NDC, 1 package rows20140813_cfecc5f4-5ce0-46d5-b1d4-92654246fcb2.zip
52533-080FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5Legacy NDC, 1 package rows20150113_33c34be1-4871-4f0a-9f52-f9606c87e1df.zip
52533-080FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3Legacy NDC, 1 package rows20140813_17606e46-f2c4-4821-b67d-a76b41a227e1.zip
52533-080FENTANYL CITRATE, BUPIVACAINE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]2Legacy NDC, 1 package rows20150113_2eb63a37-acd7-4b8a-a002-48e5060a703d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52533-080-1152533008011250 mL in 1 BAG250 mlHistorical
52533-080-6152533008061250 mL in 1 BAG250 mlHistorical
52533-080-6452533008064125 mL in 1 BAG125 mlHistorical
52533-080-7552533008075100 mL in 1 BAG100 mlHistorical