Hydromorphone HCl

Manufacturer: Cantrell Drug Company
Effective date: 2014-08-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:19:16

Label at a glance#

ProductHydromorphone HCl

Active ingredientHYDROMORPHONE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HYDROMORPHONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
52533-004-05	2019-11-27	C162847	48780-1	9855e2a2-4461-60a7-e053-dbdaa90a05bd	Hydromorphone HCl 0.4 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52533-004-05	Hydromorphone HCl	30 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52533-004	HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1	Legacy NDC, 1 package rows	20140821_e6814a56-e010-4d93-a5fd-c4d8a878aa26.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	1
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Hydromorphone HCl
HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE
Sodium Chloride
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52533-004	52533-004-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROMORPHONE HYDROCHLORIDE	L960UP2KRW	ACTIB
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, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		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 / INTRALESIONAL	0.9 %w/v		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	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		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, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 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	ELIXIR / ORAL	1 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, SOLUTION / INTRATHECAL		131 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	INJECTION, SUSPENSION / SOFT TISSUE		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 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	ENEMA / RECTAL	0.7 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		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	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	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	INJECTION / INTRACARDIAC		70 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, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		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 / INTRAVASCULAR	0.86 %w/v		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	LIQUID / NASAL	7.4 mg/1ml		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	LIQUID / SUBCUTANEOUS	0.7 %w/v		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, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
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	SPRAY / NASAL		30 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, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 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	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	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	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %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	SYRUP / ORAL		40 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	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 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	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		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
f6dde57f-87f2-4694-9d7d-5fd502fc3a87			e6814a56-e010-4d93-a5fd-c4d8a878aa26	2014-08-13		Exact identifier spl id: f6dde57f-87f2-4694-9d7d-5fd502fc3a87 spl set id: e6814a56-e010-4d93-a5fd-c4d8a878aa26

Reported adverse events (FAERS/openFDA)#

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