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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N200403-001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-01
N200403-002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-01
N200403-003HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-01
N200403-004HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-13
N200403-005HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N200403-001AP
N200403-002AP
N200403-003AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 174 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-001HYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAP2011-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-002HYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAP2011-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-003HYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAP2011-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-004HYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTION2022-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-005HYDROMORPHONE HYDROCHLORIDE0.25MG/0.5MLINJECTABLE / INJECTION2023-03-035bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N200403-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200403-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200403-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200403-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N200403-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200403-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200403-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200403-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200403-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200403-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200403-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200403-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200403-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200403-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200403-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N200403-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N200403-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N200403-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N200403-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N200403-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N200403-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N200403-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N200403-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N200403-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N200403-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N200403-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N200403-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N200403-002AP15c6f7cd8ea54…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L960UP2KRWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897756Internal RxNorm lookup
897757Internal RxNorm lookup
1433251Internal RxNorm lookup
1724383Internal RxNorm lookup
1724644Internal RxNorm lookup
2675350Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9ca2ef5-46d8-475a-a26e-f7c8becd6db7Available on FDA.report

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.f9ca2ef5-46d8-475a-a26e-f7c8becd6db72026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 200403
application number: NDA200403
ndc (product): 0409-4264
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.e9c9ef18-7dfc-4322-b2fc-29b934c30f8b2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 200403
application number: NDA200403

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