Morphine sulfate

Product NDC
67296-1375
11-digit product format
672961375
Labeler code
67296
Product ID
67296-1375_d61b7098-31be-3b30-e053-2a95a90a2d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA203849
Marketing category
ANDA
Marketing start
2015-10-26
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1375IInactivated by FDA2026-08-03
excluded packagepackage67296-137567296-1375-2IInactivated by FDA2026-08-03

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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1375-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1375-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1375-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1375-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1375-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1375-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1375-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1375-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1375-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1375-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1375-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1375-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1375-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1375-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1375-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductEExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1375-2EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1375-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203849-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-003MORPHINE SULFATEMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-004MORPHINE SULFATEMORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06
A203849-005MORPHINE SULFATEMORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203849-001AB
A203849-002AB
A203849-003AB
A203849-004AB
A203849-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-004MORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-005MORPHINE SULFATE200MGTABLET, EXTENDED RELEASE / ORALAB2015-04-065bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203849-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203849-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203849-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203849-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203849-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203849-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203849-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203849-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203849-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203849-005AB15bbf6a4d5a75…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1375-22024-01-30C16284748780-11030e365-2922-111a-e063-dadaa90a10e2504a340d-2bf8-70b9-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1375-2Morphine sulfate20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1375MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220122_504a340d-2bf8-70b9-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891881morphine sulfate 15 MG Extended Release Oral TabletPSN504a340d-2bf8-70b9-e054-00144ff8d46c4
891881morphine sulfate 15 MG Extended Release Oral TabletSCD504a340d-2bf8-70b9-e054-00144ff8d46c4
891881MS 15 MG Extended Release Oral TabletSY504a340d-2bf8-70b9-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1375-26729613750220 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67296-1375-2) 2015-10-260000-00-00NoNoCurrent