Hydromorphone Hydrochloride

Product NDC
0527-1353
11-digit product format
005271353
Labeler code
0527
Product ID
0527-1353_96651dd3-483d-41c4-b179-e7e05470d205
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA077471
Marketing category
ANDA
Marketing start
2009-12-09
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct0527-1353DDiscontinued by firm2026-08-11
excluded packagepackage0527-13530527-1353-01DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0527-1353-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0527-1353-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0527-1353-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0527-1353-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0527-1353-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0527-1353-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0527-1353-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0527-1353-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0527-1353-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0527-1353-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0527-1353-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0527-1353-01557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077471-001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-09
A077471-002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-09
A077471-003HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-09

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077471-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORAL2009-12-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077471-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORAL2009-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077471-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORAL2009-12-098072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077471-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077471-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077471-003AB174a2ff9319b5…
2021-03-12 10:30 UTC2021-03A077471-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077471-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077471-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077471-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077471-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077471-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077471-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077471-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077471-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077471-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077471-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077471-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077471-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077471-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077471-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077471-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077471-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077471-003AB1ea99ee380514…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1353-01EA - Each0527-1353a0f584aa-a1ef-4718-80bc-e59cdf91669c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydromorphone HydrochlorideACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
HydromorphoneACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKHYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
Hydromorphone HydrochlorideACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Hydromorphone HydrochlorideACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]2
HydromorphoneACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
HydromorphoneACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKHYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKHYDROMORPHONE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]2
Hydromorphone HydrochlorideACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HydromorphoneACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKHYDROMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN88dfac9a-c7ad-01be-e053-2995a90a6d4010
897696hydromorphone hydrochloride 2 MG Oral TabletSCD88dfac9a-c7ad-01be-e053-2995a90a6d4010
897696HYDROmorphone HCl 2 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897702HYDROmorphone HCl 4 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897710HYDROmorphone HCl 8 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897696hydromorphone hydrochloride 2 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2
897702hydromorphone hydrochloride 4 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2
897710hydromorphone hydrochloride 8 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1353-0100527135301100 TABLET in 1 BOTTLE, PLASTIC (0527-1353-01) 100 tablet2009-12-090000-00-00NoNoCurrent