Morphine Sulfate

Product NDC
68084-404
11-digit product format
680840404
Labeler code
68084
Product ID
68084-404_7858d41c-aa26-652f-e053-2a91aa0aeac1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075295
Marketing category
ANDA
Marketing start
2011-09-01
Marketing end
2019-10-31
Substance
MORPHINE SULFATE
Active strength
30 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68084-404DDiscontinued by firm2026-10-05
excluded productproduct68084-404DDiscontinued by firm2026-10-05
excluded packagepackage68084-40468084-404-01DDiscontinued by firm2026-10-05
excluded packagepackage68084-40468084-404-01DDiscontinued by firm2026-10-05

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 · 48 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68084-404-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68084-404-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-404-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-404-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-404-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-404-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-404-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-404-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-404-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-404-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-404-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-404-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-404-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-404-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-404-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-404-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-404-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-404-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-404-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-404-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-404-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-404-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-404-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-404-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075295-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL1998-10-28
A075295-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL1998-10-28
A075295-003MORPHINE SULFATEMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL1998-10-28
A075295-004MORPHINE SULFATEMORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2000-09-15
A075295-005MORPHINE SULFATEMORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2000-09-15

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL1998-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL1998-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL1998-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2000-09-1584e616aacf4f…
2026-09-14 22:38:342026-08A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2000-09-1584e616aacf4f…
2026-08-18 06:07:402026-07A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL1998-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL1998-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL1998-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2000-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2000-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL1998-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL1998-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL1998-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2000-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2000-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2000-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2000-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2000-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2000-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2000-09-1503ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075295-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075295-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075295-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075295-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075295-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075295-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075295-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075295-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075295-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075295-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075295-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075295-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075295-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075295-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075295-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075295-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075295-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075295-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075295-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075295-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075295-005AB1d8e5a09893c0…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-404-01EA - Each68084-404c2b9d4d7-6d75-48f6-99da-a21ccb536c1212012-07-24
68084-404-11EA - Each68084-404e8098497-537d-47f8-96cd-4054cce83e5812012-07-24