Morphine sulfate

Product NDC
0228-3092
11-digit product format
002283092
Labeler code
0228
Product ID
0228-3092_d41b3be8-7ef7-4b1d-9692-fffd13baf96d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA079040
Marketing category
ANDA
Marketing start
2014-02-04
Substance
MORPHINE SULFATE
Active strength
90 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079040-001MORPHINE SULFATEMORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16
A079040-002MORPHINE SULFATEMORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16
A079040-003MORPHINE SULFATEMORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16
A079040-004MORPHINE SULFATEMORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16
A079040-005MORPHINE SULFATEMORPHINE SULFATE90MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16
A079040-006MORPHINE SULFATEMORPHINE SULFATE120MGCAPSULE, EXTENDED RELEASE / ORALRS2013-01-16

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A079040-001MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079040-002MORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079040-003MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079040-004MORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079040-005MORPHINE SULFATE90MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A079040-006MORPHINE SULFATE120MGCAPSULE, EXTENDED RELEASE / ORALRS2013-01-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079040-001MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079040-002MORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079040-003MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079040-004MORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079040-005MORPHINE SULFATE90MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079040-006MORPHINE SULFATE120MGCAPSULE, EXTENDED RELEASE / ORALRS2013-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079040-001MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079040-002MORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079040-003MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079040-004MORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079040-005MORPHINE SULFATE90MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079040-006MORPHINE SULFATE120MGCAPSULE, EXTENDED RELEASE / ORALRS2013-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079040-001MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079040-002MORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079040-003MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079040-004MORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079040-005MORPHINE SULFATE90MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079040-006MORPHINE SULFATE120MGCAPSULE, EXTENDED RELEASE / ORALRS2013-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079040-001MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079040-002MORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079040-003MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079040-004MORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079040-005MORPHINE SULFATE90MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079040-006MORPHINE SULFATE120MGCAPSULE, EXTENDED RELEASE / ORALRS2013-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079040-001MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079040-002MORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079040-003MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079040-004MORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079040-005MORPHINE SULFATE90MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079040-006MORPHINE SULFATE120MGCAPSULE, EXTENDED RELEASE / ORALRS2013-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079040-001MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079040-002MORPHINE SULFATE45MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079040-003MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079040-004MORPHINE SULFATE75MGCAPSULE, EXTENDED RELEASE / ORAL2013-01-1603ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
Morphine sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE90 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X3P646A2J0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
892297Internal RxNorm lookup
892342Internal RxNorm lookup
892349Internal RxNorm lookup
892355Internal RxNorm lookup
894942Internal RxNorm lookup
894970Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2da87bfa-11fd-43e3-8fef-d16ebeb15680Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0228-3092-11Morphine sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10047

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
ALCOHOLINACTIVE INGREDIENT3K9958V90MMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
AMMONIAINACTIVE INGREDIENT5138Q19F1XMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
GELATININACTIVE INGREDIENT2G86QN327LMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
SHELLACINACTIVE INGREDIENT46N107B71OMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
SUCROSEINACTIVE INGREDIENTC151H8M554MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-3092MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]43Current NDC, Legacy NDC, 1 package rows20250418_2da87bfa-11fd-43e3-8fef-d16ebeb15680.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 SULFATEActavis Pharma, Inc.2da87bfa-11fd-43e3-8fef-d16ebeb156802026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079040
application number: ANDA079040
ndc (product): 0228-3092

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892297morphine sulfate 120 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892342morphine sulfate 30 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894942morphine sulfate 45 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892349morphine sulfate 60 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894970morphine sulfate 75 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892355morphine sulfate 90 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89229724 HR morphine sulfate 120 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234224 HR morphine sulfate 30 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89494224 HR morphine sulfate 45 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234924 HR morphine sulfate 60 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89497024 HR morphine sulfate 75 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89235524 HR morphine sulfate 90 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89229724 HR MS 120 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234224 HR MS 30 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89494224 HR MS 45 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234924 HR MS 60 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89497024 HR MS 75 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89235524 HR MS 90 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892297morphine sulfate 120 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892342morphine sulfate 30 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894942morphine sulfate 45 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892349morphine sulfate 60 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894970morphine sulfate 75 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892355morphine sulfate 90 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-3092-1100228309211100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3092-11) 2014-02-040000-00-00NoNoCurrent