FENTANYL CITRATE

Product NDC: 52533-025
11-digit product format: 525330025
Labeler code: 52533
Product ID: 52533-025_c96e60ea-3961-42b4-805f-320321fb9eda
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl Citrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Cantrell Drug Company
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2014-08-21
Marketing end: 0000-00-00
Substance: FENTANYL CITRATE
Active strength: 20 ug/mL
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52533-025		I	Inactivated by FDA	2026-10-12
excluded product	product	52533-025		I	Inactivated by FDA	2026-10-12
excluded product	product	52533-025		I	Inactivated by FDA	2026-10-12
excluded package	package	52533-025	52533-025-75	I	Inactivated by FDA	2026-10-12
excluded package	package	52533-025	52533-025-10	I	Inactivated by FDA	2026-10-12
excluded package	package	52533-025	52533-025-05	I	Inactivated by FDA	2026-10-12

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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52533-025-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52533-025-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52533-025-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52533-025-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52533-025-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52533-025-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52533-025-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52533-025-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52533-025-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52533-025-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52533-025-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52533-025-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52533-025-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52533-025-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52533-025-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52533-025-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52533-025-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52533-025-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52533-025-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52533-025-75	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52533-025-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52533-025-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52533-025-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52533-025-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52533-025-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52533-025-75	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52533-025-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52533-025-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52533-025-75	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52533-025-05	`ad56d346431e…`	`cc804d4bbf1e…`

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 concept	Relation	Version	Effective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3	Product name	1	20231002
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
52533-025-05	2019-11-27	C162847	48780-1	9855e2a2-4e78-60a7-e053-dbdaa90a05bd	Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
52533-025-10	2019-11-27	C162847	48780-1	9855e2a2-397b-60a7-e053-dbdaa90a05bd	Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet
52533-025-75	2019-11-27	C162847	48780-1	9855d018-e79e-cd31-e053-dbdaa90ab51a	Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 100 mL Bag

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52533-025-75	Fentanyl Citrate	100 mL in 1 BAG	INJECTION, SOLUTION	100	3
52533-025-05	FENTANYL CITRATE	30 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	30	1
52533-025-10	Fentanyl Citrate	30 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	30	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fentanyl Citrate	ACTIVE INGREDIENT	MUN5LYG46H	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
Fentanyl	ACTIVE MOIETY	UF599785JZ	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
FENTANYL CITRATE	ACTIVE INGREDIENT	MUN5LYG46H	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
FENTANYL CITRATE	ACTIVE INGREDIENT	MUN5LYG46H	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52533-025	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3	Legacy NDC, 1 package rows	20130515_f98ebc12-05ac-4777-9eb5-642fb8124b50.zip
52533-025	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1	Legacy NDC, 1 package rows	20140813_f936818a-b0bd-4811-b9b8-3fa9620a7379.zip
52533-025	FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1	Legacy NDC, 1 package rows	20140821_9622cd81-1387-41c5-a42d-469d2e757629.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MUN5LYG46H	FENTANYL CITRATE	990-73-8	FENTANYL CITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52533-025-05	52533002505	30 mL in 1 VIAL, GLASS	30 ml	Historical
52533-025-10	52533002510	30 mL in 1 SYRINGE, GLASS	30 ml	Historical
52533-025-75	52533002575	100 mL in 1 BAG	100 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet	Cantrell Drug Company	2014-08-06	HUMAN PRESCRIPTION DRUG LABEL	1
Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 100 mL Bag	Cantrell Drug Company	2013-05-15	HUMAN PRESCRIPTION DRUG LABEL	3
Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial	Cantrell Drug Company	2013-04-05	HUMAN PRESCRIPTION DRUG LABEL	1