Hydromorphone HCl

Product NDC: 52533-005
11-digit product format: 525330005
Labeler code: 52533
Product ID: 52533-005_eb7e7756-68d1-4ecd-8420-18326aac3456
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone HCl
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Cantrell Drug Company
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2014-08-13
Marketing end: 0000-00-00
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 1 mg/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	52533-005		I	Inactivated by FDA	2026-10-12
excluded product	product	52533-005		I	Inactivated by FDA	2026-10-12
excluded product	product	52533-005		I	Inactivated by FDA	2026-10-12
excluded package	package	52533-005	52533-005-45	I	Inactivated by FDA	2026-10-12
excluded package	package	52533-005	52533-005-05	I	Inactivated by FDA	2026-10-12
excluded package	package	52533-005	52533-005-10	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	52533-005-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52533-005-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52533-005-05	`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	52533-005-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52533-005-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52533-005-05	`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	52533-005-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52533-005-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52533-005-05	`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	52533-005-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52533-005-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52533-005-05	`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	52533-005-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52533-005-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52533-005-05	`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	52533-005-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52533-005-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52533-005-05	`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	52533-005-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52533-005-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52533-005-05	`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	52533-005-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52533-005-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52533-005-05	`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	52533-005-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52533-005-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52533-005-05	`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	52533-005-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52533-005-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52533-005-05	`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
c92985da-a658-b186-e763-2287eda87a86	Product name	3	20250221
96c475b3-58c7-b955-d715-0111804a3e50	Product name	5	20210512
1dd54659-b775-4fa8-a858-7f0e521fbadc	Product name	4	20200925

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52533-005-05	2019-11-27	C162847	48780-1	9855e2a2-3a5f-60a7-e053-dbdaa90a05bd	Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
52533-005-10	2019-11-27	C162847	48780-1	9855e2a2-4527-60a7-e053-dbdaa90a05bd	Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet
52533-005-45	2019-11-27	C162847	48780-1	9855e2a2-437a-60a7-e053-dbdaa90a05bd	Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Syringe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52533-005-05	Hydromorphone HCl	30 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	30	7
52533-005-45	Hydromorphone HCl	1 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	1	3
52533-005-10	Hydromorphone HCl	30 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52533-005-05	ML - Milliliter	52533-005	b34e541b-8787-462b-9da6-aedb9bdf7be4	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	7
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	7
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	7
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	2
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52533-005	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	7	Legacy NDC, 1 package rows	20140528_55c85ab0-57d5-4820-b6b0-1d0e3381571c.zip
52533-005	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3	Legacy NDC, 1 package rows	20140503_a5d20cb8-5e51-4149-a5c9-d0b016c13e05.zip
52533-005	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	2	Legacy NDC, 1 package rows	20140814_c4a6f07e-f242-4d25-be44-743b185783a1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE	71-68-1	HYDROMORPHONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52533-005-05	52533000505	30 mL in 1 VIAL, GLASS	30 ml	Historical
52533-005-10	52533000510	30 mL in 1 VIAL, GLASS	30 ml	Historical
52533-005-45	52533000545	1 mL in 1 SYRINGE, PLASTIC	1 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet	Cantrell Drug Company	2014-08-13	HUMAN PRESCRIPTION DRUG LABEL	2
Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial	Cantrell Drug Company	2014-05-27	HUMAN PRESCRIPTION DRUG LABEL	7
Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Syringe	Cantrell Drug Company	2014-05-02	HUMAN PRESCRIPTION DRUG LABEL	3