FDA.reportPublic FDA data

Dilaudid

Product NDC
76045-010
11-digit product format
760450010
Labeler code
76045
Product ID
76045-010_97bfcafb-2037-47dc-a0ae-f7b8007c47df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA019034
Marketing category
NDA
Marketing start
2016-12-16
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dilaudid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c92985da-a658-b186-e763-2287eda87a86Product name320250221
96c475b3-58c7-b955-d715-0111804a3e50Product name520210512
1dd54659-b775-4fa8-a858-7f0e521fbadcProduct name420200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76045-010-01Dilaudid1 mL in 1 SYRINGEINJECTION, SOLUTION15
76045-010-11Dilaudid10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-010-01ML - Milliliter76045-0100d0b5ab9-5d03-453e-ad3c-0a47b4c9196f12019-08-06
76045-010-10ML - Milliliter76045-0100d19c7f7-dcd6-4bf5-9503-166ec768549a12017-03-06
76045-010-11ML - Milliliter76045-010dd348941-55c9-4613-a73c-977d9f3f802912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-010DILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20240110_9eebd88a-5632-460f-b7b6-26c8a180540d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2277370Dilaudid 0.2 MG in 1 mL Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
1872752Dilaudid 0.5 MG in 0.5 ML Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
1872265Dilaudid 1 MG in 1 ML Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
1872269Dilaudid 2 MG in 1 ML Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
1433251HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
897756HYDROmorphone HCl 1 MG in 1 ML Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
897757HYDROmorphone HCl 2 MG in 1 ML Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
2277368HYDROmorphone hydrochloride 0.2 MG in 1 mL Prefilled SyringePSN9eebd88a-5632-460f-b7b6-26c8a180540d5
18727520.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe [Dilaudid]SBD9eebd88a-5632-460f-b7b6-26c8a180540d5
22773701 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled Syringe [Dilaudid]SBD9eebd88a-5632-460f-b7b6-26c8a180540d5
18722651 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe [Dilaudid]SBD9eebd88a-5632-460f-b7b6-26c8a180540d5
18722691 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe [Dilaudid]SBD9eebd88a-5632-460f-b7b6-26c8a180540d5
14332510.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled SyringeSCD9eebd88a-5632-460f-b7b6-26c8a180540d5
22773681 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled SyringeSCD9eebd88a-5632-460f-b7b6-26c8a180540d5
8977561 ML hydromorphone hydrochloride 1 MG/ML Prefilled SyringeSCD9eebd88a-5632-460f-b7b6-26c8a180540d5
8977571 ML hydromorphone hydrochloride 2 MG/ML Prefilled SyringeSCD9eebd88a-5632-460f-b7b6-26c8a180540d5
18727520.5 ML Dilaudid 1 MG/ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
22773701 ML Dilaudid 0.2 MG/ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
18722651 ML Dilaudid 1 MG/ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
18722691 ML Dilaudid 2 MG/ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
2277370Dilaudid 0.2 MG per 1 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
1872752Dilaudid 0.5 MG per 0.5 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
1872265Dilaudid 1 MG per 1 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
1872269Dilaudid 2 MG per 1 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
1433251hydromorphone HCl 0.5 MG per 0.5 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
897756hydromorphone HCl 1 MG per 1 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
897757hydromorphone HCl 2 MG per 1 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5
2277368hydromorphone hydrochloride 0.2 MG per 1 ML Prefilled SyringeSY9eebd88a-5632-460f-b7b6-26c8a180540d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76045-010-01760450010011 mL in 1 SYRINGE1 mlHistorical
76045-010-107604500101024 SYRINGE in 1 CARTON (76045-010-10) > 1 mL in 1 SYRINGE (76045-010-00) 24 syringe2016-12-160000-00-00NoNoCurrent
76045-010-117604500101110 SYRINGE in 1 CARTON (76045-010-11) / 1 mL in 1 SYRINGE (76045-010-01) 10 syringe2016-12-160000-00-00NoNoCurrent