DILAUDID

Product NDC
59011-451
11-digit product format
590110451
Labeler code
59011
Product ID
59011-451_0cc002bd-a7e7-0cd0-bf27-678460984ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Purdue Pharma LP
Application
NDA019891
Marketing category
NDA
Marketing start
1956-01-01
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
5 mg/5mL
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 productproduct59011-451DDiscontinued by firm2026-08-10
excluded packagepackage59011-45159011-451-01DDiscontinued by firm2026-08-10

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 · 30 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued 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 packagepackage59011-451-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019891-001DILAUDIDHYDROMORPHONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019891-001AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019891-001DILAUDID5MG/5MLSOLUTION / ORALAARLD, RS1992-12-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019891-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019891-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019891-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019891-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019891-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019891-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019891-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019891-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019891-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019891-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019891-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019891-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019891-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019891-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019891-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019891-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019891-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019891-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019891-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019891-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019891-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N019891-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019891-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019891-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019891-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N019891-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019891-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019891-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019891-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019891-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019891-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019891-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019891-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019891-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019891-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019891-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019891-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019891-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019891-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019891-001AA1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N019891-00165899602020-11-09Drug substance, Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N019891-00165899602020-11-09Drug substance, Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019891-00165899602020-11-09Drug substance, Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N019891-00165899602020-11-09Drug substance, Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N019891-00165899602020-11-09Drug substance, Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N019891-00165899602020-11-09Drug substance, Drug productea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59011-451-01ML - Milliliter59011-451a6db3241-f287-4856-b637-4847c602f61d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydromorphone hydrochlorideACTIVE INGREDIENTL960UP2KRWDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
hydromorphoneACTIVE MOIETYQ812464R06DILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
sucroseINACTIVE INGREDIENTC151H8M554DILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4
waterINACTIVE INGREDIENT059QF0KO0RDILAUDID (HYDROMORPHONE HYDROCHLORIDE) LIQUID DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [PURDUE PHARMA LP]4

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DilaudidHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLCd6b40e39-a57e-402c-b4f6-7041e832f8372026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019891
application number: NDA019891
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLC37565441-0d95-4743-a695-d7b3326f58a12026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019891
application number: NDA019891
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packagingfab97112-e276-40e0-bc82-0a29d7fa75fa2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019891
application number: NDA019891