Morphine Sulfate

Product NDC
40032-541
Requested package NDC
40032-541-01
11-digit product format
400320541
Labeler code
40032
Product ID
40032-541_45a60fd8-71d8-4bf4-9946-372f7b39b2b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA203602
Marketing category
ANDA
Marketing start
2015-12-16
Marketing end
0000-00-00
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage40032-54140032-541-01IInactivated by FDA2026-08-17

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203602-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL2015-12-16
A203602-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL2015-12-16
A203602-003MORPHINE SULFATEMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL2015-12-16
A203602-004MORPHINE SULFATEMORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2015-12-16
A203602-005MORPHINE SULFATEMORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2015-12-16

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL2015-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL2015-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL2015-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2015-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2015-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL2015-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL2015-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL2015-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2015-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2015-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL2015-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL2015-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL2015-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2015-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2015-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL2015-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL2015-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL2015-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2015-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2015-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORAL2015-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORAL2015-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORAL2015-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORAL2015-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORAL2015-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-12-162680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203602-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203602-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203602-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203602-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203602-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203602-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203602-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203602-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203602-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203602-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203602-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203602-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203602-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203602-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203602-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203602-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203602-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203602-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203602-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203602-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203602-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203602-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203602-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203602-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203602-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203602-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203602-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203602-005AB1301d65b070ca…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-541-01Morphine Sulfate100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
40032-541-05Morphine Sulfate500 in 1 BOTTLETABLET, EXTENDED RELEASE5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-541MORPHINE SULFATE TABLET, EXTENDED RELEASE [NOVEL LABORATORIES, INC.]6Legacy NDC, 2 package rows20191222_e044604d-f210-4411-a6e8-6a9dbdb1a9bd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATELupin Pharmaceuticals,Inc.d360a33f-6323-4b10-9e81-07e2813c2dbd2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203602
application number: ANDA203602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891881morphine sulfate 15 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
892646morphine sulfate 200 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891888morphine sulfate 30 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891893morphine sulfate 60 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891874morphine sulfate 100 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891881morphine sulfate 15 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
892646morphine sulfate 200 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891888morphine sulfate 30 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891893morphine sulfate 60 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891874MS 100 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891881MS 15 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
892646MS 200 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891888MS 30 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891893MS 60 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
40032-541-0140032054101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-541-01) 2015-12-160000-00-00NoNoCurrent