DILAUDID

Product NDC
59011-444
11-digit product format
590110444
Labeler code
59011
Product ID
59011-444_182d5b8e-6145-60ab-a2ec-a188aa83eb98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Purdue Pharma LP
Application
NDA019034
Marketing category
NDA
Marketing start
1926-01-01
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59011-444DDiscontinued by firm2026-08-11
excluded packagepackage59011-44459011-444-10DDiscontinued by firm2026-08-11

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 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59011-444-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59011-444-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59011-444-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59011-444-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59011-444-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59011-444-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59011-444-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59011-444-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59011-444-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59011-444-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59011-444-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59011-444-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59011-444-10IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59011-444-10IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59011-444-10IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59011-444-10IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59011-444-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59011-444-10EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019034-001DILAUDID-HPHYDROMORPHONE HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-01-11
N019034-002DILAUDID-HPHYDROMORPHONE HYDROCHLORIDE250MG/VIALINJECTABLE / INJECTION1994-08-04
N019034-003DILAUDIDHYDROMORPHONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30
N019034-004DILAUDIDHYDROMORPHONE HYDROCHLORIDE2MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30
N019034-005DILAUDIDHYDROMORPHONE HYDROCHLORIDE4MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30
N019034-006DILAUDIDHYDROMORPHONE HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAPRLD, RS2020-01-16
N019034-007DILAUDIDHYDROMORPHONE HYDROCHLORIDE0.5MG/0.5MLINJECTABLE / INJECTIONAPRLD, RS2017-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N019034-001AP
N019034-003AP
N019034-004AP
N019034-005AP
N019034-006AP
N019034-007AP

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N019034-00197310822032-04-23Drug product2018-02-05
N019034-00192482292034-03-12Drug product2018-02-05
N019034-00297310822032-04-23Drug product2018-02-05
N019034-00292482292034-03-12Drug product2018-02-05
N019034-00397310822032-04-23Drug product2018-02-05
N019034-00392482292034-03-12Drug product2018-02-05
N019034-00497310822032-04-23Drug product2018-02-05
N019034-00492482292034-03-12Drug product2018-02-05
N019034-00597310822032-04-23Drug product2018-02-05
N019034-00592482292034-03-12Drug product2018-02-05
N019034-00697310822032-04-23Drug product2023-05-23
N019034-00692482292034-03-12Drug product2023-05-23
N019034-00797310822032-04-23Drug product2018-02-05
N019034-00792482292034-03-12Drug product2018-02-05

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 7 · 259 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019034-001DILAUDID-HP10MG/MLINJECTABLE / INJECTIONRLD1984-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-002DILAUDID-HP250MG/VIALINJECTABLE / INJECTION1994-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-003DILAUDID1MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-004DILAUDID2MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-005DILAUDID4MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-006DILAUDID0.2MG/MLINJECTABLE / INJECTIONAPRLD, RS2020-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-007DILAUDID0.5MG/0.5MLINJECTABLE / INJECTIONAPRLD, RS2017-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-001DILAUDID-HP10MG/MLINJECTABLE / INJECTIONRLD1984-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-002DILAUDID-HP250MG/VIALINJECTABLE / INJECTION1994-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-003DILAUDID1MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-004DILAUDID2MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-005DILAUDID4MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-006DILAUDID0.2MG/MLINJECTABLE / INJECTIONAPRLD, RS2020-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-007DILAUDID0.5MG/0.5MLINJECTABLE / INJECTIONAPRLD, RS2017-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019034-001DILAUDID-HP10MG/MLINJECTABLE / INJECTIONRLD1984-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-002DILAUDID-HP250MG/VIALINJECTABLE / INJECTION1994-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-003DILAUDID1MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-004DILAUDID2MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-005DILAUDID4MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-006DILAUDID0.2MG/MLINJECTABLE / INJECTIONAPRLD, RS2020-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-007DILAUDID0.5MG/0.5MLINJECTABLE / INJECTIONAPRLD, RS2017-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-001DILAUDID-HP10MG/MLINJECTABLE / INJECTIONRLD1984-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-002DILAUDID-HP250MG/VIALINJECTABLE / INJECTION1994-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-003DILAUDID1MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-004DILAUDID2MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-005DILAUDID4MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-006DILAUDID0.2MG/MLINJECTABLE / INJECTIONAPRLD, RS2020-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-007DILAUDID0.5MG/0.5MLINJECTABLE / INJECTIONAPRLD, RS2017-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-001DILAUDID-HP10MG/MLINJECTABLE / INJECTIONRLD1984-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-002DILAUDID-HP250MG/VIALINJECTABLE / INJECTION1994-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-003DILAUDID1MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-004DILAUDID2MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-005DILAUDID4MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-006DILAUDID0.2MG/MLINJECTABLE / INJECTIONAPRLD, RS2020-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-007DILAUDID0.5MG/0.5MLINJECTABLE / INJECTIONAPRLD, RS2017-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-001DILAUDID-HP10MG/MLINJECTABLE / INJECTIONRLD1984-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-002DILAUDID-HP250MG/VIALINJECTABLE / INJECTION1994-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-003DILAUDID1MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-004DILAUDID2MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-005DILAUDID4MG/MLINJECTABLE / INJECTIONAPRLD, RS2009-04-3003ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019034-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019034-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019034-007AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-006AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019034-007AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-005AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-006AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019034-007AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019034-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019034-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019034-005AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019034-006AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019034-007AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019034-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019034-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019034-005AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019034-006AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019034-007AP15bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 13 · 518 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019034-00197310822032-04-23Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00192482292034-03-12Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00297310822032-04-23Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00292482292034-03-12Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00397310822032-04-23Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00392482292034-03-12Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00497310822032-04-23Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00492482292034-03-12Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00597310822032-04-23Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00592482292034-03-12Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00697310822032-04-23Drug product2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00692482292034-03-12Drug product2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00797310822032-04-23Drug product2018-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019034-00792482292034-03-12Drug product2018-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00197310822032-04-23Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00192482292034-03-12Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00297310822032-04-23Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00292482292034-03-12Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00397310822032-04-23Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00392482292034-03-12Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00497310822032-04-23Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00492482292034-03-12Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00597310822032-04-23Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00592482292034-03-12Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00697310822032-04-23Drug product2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00692482292034-03-12Drug product2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00797310822032-04-23Drug product2018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019034-00792482292034-03-12Drug product2018-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019034-00197310822032-04-23Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00192482292034-03-12Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00297310822032-04-23Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00292482292034-03-12Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00397310822032-04-23Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00392482292034-03-12Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00497310822032-04-23Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00492482292034-03-12Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00597310822032-04-23Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00592482292034-03-12Drug product2018-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00697310822032-04-23Drug product2023-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019034-00692482292034-03-12Drug product2023-05-236a471c1ec25d…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59011-444-10ML - Milliliter59011-44432189f2a-0776-4a8d-9e56-2715f5f279c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydromorphone hydrochlorideACTIVE INGREDIENTL960UP2KRWDILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PURDUE PHARMA LP]9
hydromorphoneACTIVE MOIETYQ812464R06DILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PURDUE PHARMA LP]9
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPDILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PURDUE PHARMA LP]9
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PURDUE PHARMA LP]9
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRDILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PURDUE PHARMA LP]9
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PURDUE PHARMA LP]9
waterINACTIVE INGREDIENT059QF0KO0RDILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION DILAUDID HP (HYDROMORPHONE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PURDUE PHARMA LP]9

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
DilaudidHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLC9eebd88a-5632-460f-b7b6-26c8a180540d2025-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019034
application number: NDA019034
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLCe034eb96-03e0-46e1-8b92-5e1f94555e7b2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019034
application number: NDA019034