MORPHINE SULFATE

Product NDC
55700-905
11-digit product format
557000905
Labeler code
55700
Product ID
55700-905_9870ddc2-6ca6-436e-8f4b-1be9d8a11526
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA212451
Marketing category
ANDA
Marketing start
2021-03-18
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
30 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-905DDiscontinued by firm2026-09-14
excluded packagepackage55700-90555700-905-30DDiscontinued by firm2026-09-14
excluded packagepackage55700-90555700-905-60DDiscontinued by firm2026-09-14

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 · 30 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-905-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-905-60DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-905-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-905-60DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-905-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-905-60DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-905-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-905-60DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-905-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-905-60DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-905-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-905-60DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-905-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-905-60DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-905-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-905-60DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-905-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-905-60DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-905-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-905-30IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212451-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET / ORALAB2020-12-03
A212451-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET / ORALAB2020-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212451-001AB
A212451-002AB

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 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-0384e616aacf4f…
2026-09-14 22:38:342026-08A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-0384e616aacf4f…
2026-08-18 06:07:402026-07A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-034b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212451-001MORPHINE SULFATE15MGTABLET / ORALAB2020-12-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212451-002MORPHINE SULFATE30MGTABLET / ORALAB2020-12-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212451-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212451-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A212451-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212451-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212451-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212451-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212451-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212451-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212451-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212451-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212451-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212451-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212451-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212451-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212451-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212451-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212451-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212451-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212451-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212451-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212451-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212451-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212451-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212451-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212451-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212451-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212451-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212451-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212451-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212451-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212451-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212451-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212451-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212451-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212451-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212451-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212451-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212451-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212451-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212451-002AB1bb7c543d1eb4…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2021-12-28 21:50 UTC2021-12A212451-001CGT2021-08-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A212451-002CGT2021-08-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212451-001CGT2021-08-1087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212451-002CGT2021-08-1087673890dc5c…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-905-30EA - Each55700-90538452548-0b6f-4a67-ac57-b1d6fab144d312021-06-02
55700-905-60EA - Each55700-905deaa9544-bac7-44d3-a543-dbee2dba1c7a12021-04-08

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 SULFATESt. Mary's Medical Park Pharmacy57ee014e-744e-65e1-e063-6394a90a8c932026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212451
application number: ANDA212451
MORPHINE SULFATEMORPHINE SULFATEBryant Ranch Prepackd1b0b4ac-69d9-44bf-b7a3-229bd89b9fd62026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212451
application number: ANDA212451
Morphine SulfateMORPHINE SULFATEAmerican Health Packagingd66d0cfb-9bfe-490c-90ee-49481c567e852025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212451
application number: ANDA212451
MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLC07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a2025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212451
application number: ANDA212451
MORPHINE SULFATEMORPHINE SULFATEBryant Ranch Prepack905cd842-2c86-4318-a6c4-92f49de145b32025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212451
application number: ANDA212451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-905-305570009053030 TABLET in 1 BOTTLE (55700-905-30) 30 tablet2021-04-160000-00-00NoNoCurrent
55700-905-605570009056060 TABLET in 1 BOTTLE (55700-905-60) 60 tablet2021-03-180000-00-00NoNoCurrent