FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
0409-4264
11-digit product format
004094264
Labeler code
0409
Product ID
0409-4264_766e302a-2d03-4d93-b237-2348b57ee517
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
NDA200403
Marketing category
NDA
Marketing start
2022-05-27
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
.5 mg/.5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE.5 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897756, 897757, 1433251, 1724383, 1724644, 2675350

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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4264-01Hydromorphone Hydrochloride10 in 1 CELLO PACKINJECTION, SOLUTION1012
0409-4264-11Hydromorphone Hydrochloride0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4264-01ML - Milliliter0409-426461447661-c393-43af-a159-b92d8df826ca12022-06-06
0409-4264-11ML - Milliliter0409-4264dc35d8d6-76f7-4c64-9edb-6a9ad37fb1fa12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4264HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]9Current NDC, Legacy NDC, 2 package rows20240517_f9ca2ef5-46d8-475a-a26e-f7c8becd6db7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433251HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled SyringePSNf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
1724383HYDROmorphone HCl 1 MG in 1 ML CartridgePSNf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
897756HYDROmorphone HCl 1 MG in 1 ML Prefilled SyringePSNf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
1724644HYDROmorphone HCl 2 MG in 1 ML CartridgePSNf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
897757HYDROmorphone HCl 2 MG in 1 ML Prefilled SyringePSNf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
2675350HYDROmorphone hydrochloride 0.25 MG in 0.5 ML Prefilled SyringePSNf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
26753500.5 ML hydromorphone hydrochloride 0.5 MG/ML Prefilled SyringeSCDf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
14332510.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled SyringeSCDf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
17243831 ML hydromorphone hydrochloride 1 MG/ML CartridgeSCDf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
8977561 ML hydromorphone hydrochloride 1 MG/ML Prefilled SyringeSCDf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
17246441 ML hydromorphone hydrochloride 2 MG/ML CartridgeSCDf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
8977571 ML hydromorphone hydrochloride 2 MG/ML Prefilled SyringeSCDf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
1433251hydromorphone HCl 0.5 MG per 0.5 ML Prefilled SyringeSYf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
1724383hydromorphone HCl 1 MG per 1 ML CartridgeSYf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
897756hydromorphone HCl 1 MG per 1 ML Prefilled SyringeSYf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
1724644hydromorphone HCl 2 MG per 1 ML CartridgeSYf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
897757hydromorphone HCl 2 MG per 1 ML Prefilled SyringeSYf9ca2ef5-46d8-475a-a26e-f7c8becd6db712
2675350hydromorphone hydrochloride 0.25 MG per 0.5 ML Prefilled SyringeSYf9ca2ef5-46d8-475a-a26e-f7c8becd6db712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4264-010040942640110 SYRINGE in 1 CELLO PACK (0409-4264-01) / .5 mL in 1 SYRINGE (0409-4264-11) 10 syringe2022-05-270000-00-00NoNoCurrent
0409-4264-11004094264110.5 mL in 1 SYRINGE0.5 mlHistorical