Morphine Sulfate

Product NDC
0115-1279
11-digit product format
001151279
Labeler code
0115
Product ID
0115-1279_b2330bfc-8b32-421e-ade5-2076ee23cebb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA200411
Marketing category
ANDA
Marketing start
2016-04-12
Substance
MORPHINE SULFATE
Active strength
50 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 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200411-001MORPHINE SULFATEMORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12
A200411-002MORPHINE SULFATEMORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12
A200411-003MORPHINE SULFATEMORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12
A200411-004MORPHINE SULFATEMORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12
A200411-005MORPHINE SULFATEMORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12
A200411-006MORPHINE SULFATEMORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12
A200411-007MORPHINE SULFATEMORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-25

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 8 · 284 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200411-001MORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200411-002MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200411-003MORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200411-004MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200411-005MORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200411-006MORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200411-007MORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200411-001MORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200411-002MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200411-003MORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200411-004MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200411-005MORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200411-006MORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200411-007MORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A200411-001MORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200411-002MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200411-003MORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200411-004MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200411-005MORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200411-006MORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200411-007MORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200411-001MORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200411-002MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200411-003MORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200411-004MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200411-005MORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200411-006MORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200411-007MORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200411-001MORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200411-002MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200411-003MORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200411-004MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200411-005MORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200411-006MORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200411-007MORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200411-001MORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200411-002MORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200411-003MORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200411-004MORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200411-005MORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORAL2016-04-1203ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200411-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200411-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200411-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200411-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200411-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200411-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200411-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200411-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200411-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200411-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200411-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200411-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200411-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200411-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200411-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200411-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200411-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200411-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200411-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200411-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200411-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200411-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200411-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200411-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200411-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200411-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200411-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200411-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200411-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200411-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200411-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200411-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200411-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200411-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200411-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200411-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200411-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200411-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200411-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200411-004AB187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE50 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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
892345Internal RxNorm lookup
892352Internal RxNorm lookup
892554Internal RxNorm lookup
892596Internal RxNorm lookup
894801Internal RxNorm lookup
894814Internal RxNorm lookup
1303736Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7e9a4b3-a2ee-4f0a-becd-6ef90867332bAvailable 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
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
0115-1279-01Morphine Sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10042
0115-1279-03Morphine Sulfate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100042
0115-1279-08Morphine Sulfate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1279-01EA - Each0115-1279dc99b6eb-2c9b-4cbc-9cb7-9879126e81ed12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1279MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]37Current NDC, Legacy NDC, 3 package rows20240215_f7e9a4b3-a2ee-4f0a-becd-6ef90867332b.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 SULFATEAmneal Pharmaceuticals of New York LLCf7e9a4b3-a2ee-4f0a-becd-6ef90867332b2025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200411
application number: ANDA200411
ndc (product): 0115-1279

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892554morphine sulfate 100 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892596morphine sulfate 20 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892345morphine sulfate 30 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
1303736morphine sulfate 40 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894801morphine sulfate 50 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352morphine sulfate 60 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894814morphine sulfate 80 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892554morphine sulfate 100 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892596morphine sulfate 20 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892345morphine sulfate 30 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
1303736morphine sulfate 40 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894801morphine sulfate 50 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352morphine sulfate 60 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894814morphine sulfate 80 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352morphine sulfate 60 MG 12-24 HR Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892554MS 100 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892596MS 20 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892345MS 30 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
1303736MS 40 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894801MS 50 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352MS 60 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894814MS 80 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1279-0100115127901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-01) 2016-04-120000-00-00NoNoCurrent
0115-1279-03001151279031000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-03) 2016-04-120000-00-00NoNoCurrent
0115-1279-080011512790830 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-08) 2016-04-120000-00-00NoNoCurrent