Morphine Sulfate

Product NDC
27808-084
Requested package NDC
27808-084-01
11-digit product format
278080084
Labeler code
27808
Product ID
27808-084_1d7c0b30-da21-4d70-9047-3ad8ac879497
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Tris Pharma Inc
Application
ANDA203518
Marketing category
ANDA
Marketing start
2015-09-21
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
10 mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage27808-08427808-084-01DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A203518-001MORPHINE SULFATEMORPHINE SULFATE10MG/5MLSOLUTION / ORAL2015-05-12
A203518-002MORPHINE SULFATEMORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203518-002AA

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 06:07:402026-07A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2015-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203518-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2015-05-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203518-002MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2015-05-12bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203518-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203518-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203518-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203518-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203518-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203518-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203518-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203518-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203518-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203518-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203518-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203518-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203518-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203518-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203518-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203518-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203518-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203518-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203518-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203518-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203518-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203518-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203518-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203518-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203518-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203518-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203518-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203518-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203518-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203518-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203518-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203518-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203518-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203518-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203518-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203518-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203518-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203518-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203518-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203518-001AA1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
27808-084-01Morphine Sulfate1 in 1 CARTONSOLUTION137
27808-084-01Morphine Sulfate100 mL in 1 BOTTLE, UNIT-DOSESOLUTION10037
27808-084-02Morphine Sulfate500 mL in 1 BOTTLESOLUTION50037

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
SORBITOLINACTIVE INGREDIENT506T60A25RMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-084MORPHINE SULFATE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]35Legacy NDC, 3 package rows20250507_d8598654-94ad-4cfb-81d2-9b68e013a428.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepack367d508b-3226-42a9-8dc6-f67cdc9979f32026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203518
application number: ANDA203518
Morphine SulfateMORPHINE SULFATEAmerican Health Packaging5422cdac-8073-41fc-8665-ffe9797f5c022026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203518
application number: ANDA203518
Morphine SulfateMORPHINE SULFATECranbury Pharmaceuticals, LLCd8598654-94ad-4cfb-81d2-9b68e013a4282026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203518
application number: ANDA203518
ndc (package): 27808-084-01
ndc (product): 27808-084
ndc11 (package): 27808008401
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepack9bb1fef7-4159-4dca-8a8c-37e53ccc6bab2024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203518
application number: ANDA203518
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackb7b86b6d-9a39-494c-bf65-f62e4cdc58072023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203518
application number: ANDA203518

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSNd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNd8598654-94ad-4cfb-81d2-9b68e013a42837
892589morphine sulfate 2 MG/ML Oral SolutionSCDd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 20 MG/ML Oral SolutionSCDd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892589morphine sulfate 10 MG per 5 ML Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892589MS 2 MG/ML Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892625MS 20 MG/ML Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27808-084-01278080084011 BOTTLE, UNIT-DOSE in 1 CARTON (27808-084-01) > 100 mL in 1 BOTTLE, UNIT-DOSE2015-09-210000-00-00NoNoCurrent