morphine sulfate

Product NDC
60951-653
11-digit product format
609510653
Labeler code
60951
Product ID
60951-653_64d03acf-7e17-4be0-b5c0-05dea1125e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA075295
Marketing category
ANDA
Marketing start
1998-10-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60951-653DDiscontinued by firm2026-10-05
excluded packagepackage60951-65360951-653-70DDiscontinued 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 · 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 packagepackage60951-653-70d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60951-653-70f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60951-653-702ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60951-653-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60951-653-70cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60951-653-70cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60951-653-70302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60951-653-70ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60951-653-700efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60951-653-70ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60951-653-70367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60951-653-70557ba5c1ecfa…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 4 of 5 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A075295-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075295-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075295-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075295-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075295-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075295-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075295-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075295-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075295-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075295-005AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075295-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075295-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075295-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075295-004AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075295-005AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075295-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A075295-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A075295-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A075295-004AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A075295-005AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075295-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A075295-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A075295-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A075295-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A075295-005AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075295-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075295-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075295-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075295-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075295-005AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075295-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075295-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075295-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075295-004AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075295-005AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075295-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075295-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075295-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075295-004AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075295-005AB1a67488948f0b…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60951-653-70EA - Each60951-653c249aec3-1356-4d5c-a796-7231a985a26d12012-07-24

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSN1798cf82-9893-4de2-89a5-2fa4f229a5c52
891881morphine sulfate 15 MG Extended Release Oral TabletPSN1798cf82-9893-4de2-89a5-2fa4f229a5c52
891888morphine sulfate 30 MG Extended Release Oral TabletPSN1798cf82-9893-4de2-89a5-2fa4f229a5c52
891893morphine sulfate 60 MG Extended Release Oral TabletPSN1798cf82-9893-4de2-89a5-2fa4f229a5c52
891874morphine sulfate 100 MG Extended Release Oral TabletSCD1798cf82-9893-4de2-89a5-2fa4f229a5c52
891881morphine sulfate 15 MG Extended Release Oral TabletSCD1798cf82-9893-4de2-89a5-2fa4f229a5c52
891888morphine sulfate 30 MG Extended Release Oral TabletSCD1798cf82-9893-4de2-89a5-2fa4f229a5c52
891893morphine sulfate 60 MG Extended Release Oral TabletSCD1798cf82-9893-4de2-89a5-2fa4f229a5c52
891874MS 100 MG Extended Release Oral TabletSY1798cf82-9893-4de2-89a5-2fa4f229a5c52
891881MS 15 MG Extended Release Oral TabletSY1798cf82-9893-4de2-89a5-2fa4f229a5c52
891888MS 30 MG Extended Release Oral TabletSY1798cf82-9893-4de2-89a5-2fa4f229a5c52
891893MS 60 MG Extended Release Oral TabletSY1798cf82-9893-4de2-89a5-2fa4f229a5c52