MORPHINE SULFATE

Product NDC
61919-923
11-digit product format
619190923
Labeler code
61919
Product ID
61919-923_82d82270-8253-4850-b714-6f917aea6448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA074862
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
30 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-923IInactivated by FDA2026-08-10
excluded packagepackage61919-92361919-923-30IInactivated by FDA2026-08-10
excluded packagepackage61919-92361919-923-60IInactivated by FDA2026-08-10

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-923-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-923-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-923-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-923-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-923-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-923-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-923-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-923-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-923-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-923-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-923-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-923-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-923-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-923-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-923-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-923-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-923-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-923-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-923-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-923-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-923-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-923-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-923-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-923-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-923-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-923-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-923-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-923-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-923-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-923-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-923-30fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-923-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-923-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-923-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-923-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-923-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-923-308dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-923-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-923-30e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-923-60e2bbac7714bc…27bdfed8d636…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074862-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07
A074862-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07
A074862-003MORPHINE SULFATEMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074862-001AB
A074862-002AB
A074862-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074862-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074862-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074862-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074862-001AB18072bd15b7f6…

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
61919-923-302020-01-31C16284748780-19d75b9cf-fb18-f424-e053-dadaa90a57ceMORPHINE SULFATE
61919-923-602020-01-31C16284748780-19d75b9cf-fb18-f424-e053-dadaa90a57ceMORPHINE SULFATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-923-30MORPHINE SULFATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
61919-923-60MORPHINE SULFATE60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-923-30EA - Each61919-92387c1e0ea-5628-496c-a474-bdd18d8c207112015-12-02
61919-923-60EA - Each61919-9234f8cb4cd-4118-471a-829a-dc328f5f17bd12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-923MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3Legacy NDC, 2 package rows20151113_4cb3ea11-5891-415f-b043-4c084396e98e.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 Sulfate Extended ReleaseMORPHINE SULFATEMajor Pharmaceuticalsdbb37dfd-0196-45f7-b9ca-393f56cf1d282026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
Morphine Sulfate Extended ReleaseMORPHINE SULFATERhodes Pharmaceuticals LLC19c7d9cc-6ce2-4c5c-8c3f-c24fd33428042026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
Morphine Sulfate ERMORPHINE SULFATEBryant Ranch Prepack872ceecb-1f14-7a43-7451-e4650a01fbd92026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackcc3b491c-a206-3027-54f0-f87c0dd40a7f2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
Morphine Sulfate Extended ReleaseMORPHINE SULFATEAmerican Health Packagingf915420d-981d-455b-b4cf-67c8e201a1362024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891888morphine sulfate 30 MG Extended Release Oral TabletPSN4cb3ea11-5891-415f-b043-4c084396e98e3
891888morphine sulfate 30 MG Extended Release Oral TabletSCD4cb3ea11-5891-415f-b043-4c084396e98e3
891888MS 30 MG Extended Release Oral TabletSY4cb3ea11-5891-415f-b043-4c084396e98e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-923-306191909233030 in 1 BOTTLEHistorical
61919-923-606191909236060 in 1 BOTTLEHistorical