Morphine sulfate

Product NDC
0228-4270
11-digit product format
002284270
Labeler code
0228
Product ID
0228-4270_b3ebf58d-9730-4a88-802c-5c27fb2b090f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA203849
Marketing category
ANDA
Marketing start
2015-10-26
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0228-4270DDiscontinued by firm2026-08-03
excluded packagepackage0228-42700228-4270-11DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0228-4270DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0228-42700228-4270-11DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203849-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-003MORPHINE SULFATEMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-004MORPHINE SULFATEMORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-005MORPHINE SULFATEMORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A203849-001AB
A203849-002AB
A203849-003AB
A203849-004AB
A203849-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203849-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203849-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-005AB15bbf6a4d5a75…

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-4270-11Morphine sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-4270-11EA - Each0228-427003c12f73-aeda-41a4-98a0-92392c8814d912015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)INACTIVE INGREDIENT12VCE9HR9EMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-4270MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]19Legacy NDC, 1 package rows20240604_75fb4282-0bbd-4d63-a7d1-5142780a4fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891881morphine sulfate 15 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
892646morphine sulfate 200 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891888morphine sulfate 30 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891893morphine sulfate 60 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891874morphine sulfate 100 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891881morphine sulfate 15 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
892646morphine sulfate 200 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891888morphine sulfate 30 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891893morphine sulfate 60 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891874MS 100 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891881MS 15 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
892646MS 200 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891888MS 30 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891893MS 60 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891881morphine sulfate 15 MG Extended Release Oral TabletPSN504a340d-2bf8-70b9-e054-00144ff8d46c4
891881morphine sulfate 15 MG Extended Release Oral TabletSCD504a340d-2bf8-70b9-e054-00144ff8d46c4
891881MS 15 MG Extended Release Oral TabletSY504a340d-2bf8-70b9-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-4270-1100228427011100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4270-11) 2015-10-260000-00-00NoNoCurrent