Hydromorphone HCl

Product NDC: 52533-146
11-digit product format: 525330146
Labeler code: 52533
Product ID: 52533-146_c746ac99-67f5-4392-a757-763d639b6659
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: 2014-08-20
Marketing end: 0000-00-00
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 2 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52533-146		I	Inactivated by FDA	2026-10-12
excluded product	product	52533-146		I	Inactivated by FDA	2026-10-12
excluded package	package	52533-146	52533-146-10	I	Inactivated by FDA	2026-10-12
excluded package	package	52533-146	52533-146-05	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 2 · 88 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 package	package	52533-146-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52533-146-05	`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 package	package	52533-146-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52533-146-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52533-146-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52533-146-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52533-146-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52533-146-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52533-146-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52533-146-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52533-146-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52533-146-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52533-146-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52533-146-05	`1332a3947898…`	`d4bfe170f9cd…`

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
52533-146-05	2019-11-27	C162847	48780-1	9855e2a2-4cad-60a7-e053-dbdaa90a05bd	Hydromorphone HCl 2 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
52533-146-10	2019-11-27	C162847	48780-1	9855e2a2-4db8-60a7-e053-dbdaa90a05bd	Hydromorphone HCl 2 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52533-146-05	Hydromorphone HCl	30 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	30		1
52533-146-10	Hydromorphone HCl	30 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	30		1

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]	1
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52533-146	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1	Legacy NDC, 1 package rows	20140814_42088b45-49ef-4cb5-a006-8b9a70c6969f.zip
52533-146	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1	Legacy NDC, 1 package rows	20140820_8d06f43f-78aa-4008-9fa3-60e4cf19d9e8.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
897745	HYDROmorphone HCl 2 MG/ML Injectable Solution	PSN	42088b45-49ef-4cb5-a006-8b9a70c6969f	1
897745	HYDROmorphone HCl 2 MG/ML Injectable Solution	PSN	8d06f43f-78aa-4008-9fa3-60e4cf19d9e8	1
897745	hydromorphone hydrochloride 2 MG/ML Injectable Solution	SCD	42088b45-49ef-4cb5-a006-8b9a70c6969f	1
897745	hydromorphone hydrochloride 2 MG/ML Injectable Solution	SCD	8d06f43f-78aa-4008-9fa3-60e4cf19d9e8	1
897745	hydromorphone HCl 2 MG/ML Injectable Solution	SY	42088b45-49ef-4cb5-a006-8b9a70c6969f	1
897745	hydromorphone HCl 2 MG/ML Injectable Solution	SY	8d06f43f-78aa-4008-9fa3-60e4cf19d9e8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52533-146-05	52533014605	30 mL in 1 VIAL, GLASS	30 ml	Historical
52533-146-10	52533014610	30 mL in 1 VIAL, GLASS	30 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone HCl 2 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial	Cantrell Drug Company	2014-08-20	HUMAN PRESCRIPTION DRUG LABEL	1
Hydromorphone HCl 2 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet	Cantrell Drug Company	2014-08-13	HUMAN PRESCRIPTION DRUG LABEL	1