Morphine sulfate

Product NDC
71335-3080
Requested package NDC
71335-3080-1
11-digit product format
713353080
Labeler code
71335
Product ID
71335-3080_fd13b360-b1b6-4fc5-869a-1a98cd211b5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078761
Marketing category
ANDA
Marketing start
2012-05-11
Substance
MORPHINE SULFATE
Active strength
100 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 43.

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
A078761-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11
A078761-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11
A078761-003MORPHINE SULFATEMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11
A078761-004MORPHINE SULFATEMORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11
A078761-005MORPHINE SULFATEMORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078761-001AB
A078761-002AB
A078761-003AB
A078761-004AB
A078761-005AB

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1184e616aacf4f…
2026-08-18 06:07:402026-07A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2012-05-1103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078761-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078761-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078761-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078761-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078761-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A078761-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078761-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078761-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078761-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078761-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078761-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078761-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078761-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078761-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078761-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE100 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891874Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07993f6c-146b-4728-a2da-6e93089f78ffAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71335-3080-1Morphine sulfate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
71335-3080-2Morphine sulfate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
71335-3080-3Morphine sulfate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
71335-3080-4Morphine sulfate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack595243fe-a4b1-479a-99d6-a084a41818912026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATESun Pharmaceutical Industries, Inc.736c9b80-682c-4cda-bf18-61b18de0bd392026-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack07993f6c-146b-4728-a2da-6e93089f78ff2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
ndc (package): 71335-3080-1
ndc (product): 71335-3080
ndc11 (package): 71335308001
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack3a89d0ca-4ff8-4bdc-8ea8-9ad591ce72262026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack47ea2424-ce2f-4b3b-b393-da1886e7a3832025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack2f15f27b-95ed-4cc8-8937-eae07917a6dd2024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack20af0f0e-45cc-4795-97ef-90b659575b342024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack3e310662-16e8-4179-883e-efbca736b14d2024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack7f65fa22-c3fc-4413-8a07-2c6be621b7bf2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepackfd98b881-5466-457b-b5af-f102aec615462024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack9a1ca529-8268-4be3-b03f-b2f2238cc9dc2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepackfb9f929b-8c5a-442b-9695-9d3d45272a5e2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack73a39ce5-b2ab-47b9-8860-796f1d5bc8d82024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepackad08cd86-3825-4e77-bbe8-f6333a9ca9d72024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078761
application number: ANDA078761

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSN07993f6c-146b-4728-a2da-6e93089f78ff1
891874morphine sulfate 100 MG Extended Release Oral TabletSCD07993f6c-146b-4728-a2da-6e93089f78ff1
891874MS 100 MG Extended Release Oral TabletSY07993f6c-146b-4728-a2da-6e93089f78ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3080-17133530800190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-1) 2026-02-13NoNoCurrent