Hydromorphone Hydrochloride

Product NDC
71335-0303
11-digit product format
713350303
Labeler code
71335
Product ID
71335-0303_f0b78f98-d632-40a9-a5aa-317ed5d50338
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077471
Marketing category
ANDA
Marketing start
2009-12-09
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0303DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-0DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-1DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-2DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-3DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-4DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-5DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-6DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-7DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-8DDiscontinued by firm2026-08-11
excluded packagepackage71335-030371335-0303-9DDiscontinued 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 2 · 110 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 packagepackage71335-0303-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0303-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0303-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0303-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0303-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0303-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0303-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0303-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0303-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0303-0cdf11ea48f46…ba0047e9e063…

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
71335-0303-1EA - Each71335-03039f22e4b0-bf7c-4b64-ac38-bd9d87514d1912018-06-11
71335-0303-7EA - Each71335-03033618b7a9-bb9b-46ab-8a02-cb69ee6d5cec12018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0303-07133503030090 TABLET in 1 BOTTLE (71335-0303-0) 90 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-17133503030130 TABLET in 1 BOTTLE (71335-0303-1) 30 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-271335030302180 TABLET in 1 BOTTLE (71335-0303-2) 180 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-371335030303120 TABLET in 1 BOTTLE (71335-0303-3) 120 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-47133503030420 TABLET in 1 BOTTLE (71335-0303-4) 20 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-57133503030525 TABLET in 1 BOTTLE (71335-0303-5) 25 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-671335030306100 TABLET in 1 BOTTLE (71335-0303-6) 100 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-77133503030760 TABLET in 1 BOTTLE (71335-0303-7) 60 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-87133503030856 TABLET in 1 BOTTLE (71335-0303-8) 56 tablet2009-12-090000-00-00NoNoCurrent
71335-0303-971335030309140 TABLET in 1 BOTTLE (71335-0303-9) 140 tablet2009-12-090000-00-00NoNoCurrent