MORPHINE SULFATE

Product NDC
0406-8320
11-digit product format
004068320
Labeler code
0406
Product ID
0406-8320_6873cac9-e7d5-4db2-851d-528268b483e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA076438
Marketing category
ANDA
Marketing start
2003-07-03
Substance
MORPHINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076438-001MORPHINE SULFATEMORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03
A076438-002MORPHINE SULFATEMORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076438-001AB
A076438-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076438-001MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076438-002MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2003-07-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076438-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076438-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076438-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076438-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076438-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076438-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076438-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076438-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076438-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076438-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076438-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076438-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076438-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076438-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076438-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076438-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076438-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076438-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076438-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076438-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076438-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076438-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076438-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076438-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076438-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076438-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076438-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076438-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076438-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076438-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076438-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076438-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076438-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076438-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076438-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076438-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076438-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076438-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076438-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076438-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
MORPHINE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE200 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891874Internal RxNorm lookup
891881Internal RxNorm lookup
891888Internal RxNorm lookup
891893Internal RxNorm lookup
892646Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
533034fd-c8e7-495b-8874-0db41bd1e65aAvailable 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
0406-8320-01MORPHINE SULFATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8320-01EA - Each0406-83201feb3606-f2d6-49fd-9da0-d55ccaddb15612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
TRIACETININACTIVE INGREDIENTXHX3C3X673MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8320MORPHINE SULFATE TABLET, EXTENDED RELEASE [SPECGX LLC]38Current NDC, Legacy NDC, 1 package rows20240724_533034fd-c8e7-495b-8874-0db41bd1e65a.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 SULFATESpecGx LLC533034fd-c8e7-495b-8874-0db41bd1e65a2023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076438
application number: ANDA076438
ndc (product): 0406-8320

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891881morphine sulfate 15 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
892646morphine sulfate 200 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891888morphine sulfate 30 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891893morphine sulfate 60 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891874morphine sulfate 100 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891881morphine sulfate 15 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
892646morphine sulfate 200 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891888morphine sulfate 30 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891893morphine sulfate 60 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891874MS 100 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
891881MS 15 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
892646MS 200 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
891888MS 30 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
891893MS 60 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-8320-0100406832001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8320-01) 2003-07-030000-00-00NoNoCurrent