Hydromorphone Hydrochloride

Product NDC
35356-814
11-digit product format
353560814
Labeler code
35356
Product ID
35356-814_40f9e063-f7df-47c4-be55-ecb173878afb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077471
Marketing category
ANDA
Marketing start
2009-12-09
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-814DDiscontinued by firm2026-08-11
excluded packagepackage35356-81435356-814-01DDiscontinued by firm2026-08-11
excluded packagepackage35356-81435356-814-30DDiscontinued by firm2026-08-11
excluded packagepackage35356-81435356-814-60DDiscontinued by firm2026-08-11
excluded packagepackage35356-81435356-814-90DDiscontinued 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 · 60 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 packagepackage35356-814-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-814-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-814-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-814-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-814-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-814-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-814-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-814-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-814-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-814-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-814-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-814-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-814-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-814-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-814-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-814-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-814-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-814-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-814-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-814-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-814-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-814-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-814-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-814-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-814-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-814-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-814-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-814-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-814-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-814-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-814-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-814-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-814-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-814-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-814-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-814-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-814-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-814-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-814-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-814-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-814-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-814-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-814-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-814-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-814-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-814-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-814-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-814-01557ba5c1ecfa…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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-814-30EA - Each35356-81438df4b60-3d68-4a7b-81a8-8c67c4e9d35d12013-04-01
35356-814-60EA - Each35356-81482a32004-19a8-4841-8111-e029b6aab78b12013-04-01
35356-814-90EA - Each35356-8141ae497b3-ad5c-4094-83e4-35958b5a103712013-04-01

DailyMed Socrata Ingredients#