Morphine Sulfate

Product NDC
0121-0825
11-digit product format
001210825
Labeler code
0121
Product ID
0121-0825_fb581fb2-a860-4eb7-a222-9ee0db19e178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI
Application
ANDA206573
Marketing category
ANDA
Marketing start
2016-11-14
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
100 mg/5mL
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0121-0825DDiscontinued by firm2026-08-03
excluded packagepackage0121-08250121-0825-01DDiscontinued by firm2026-08-03
excluded packagepackage0121-08250121-0825-04DDiscontinued by firm2026-08-03
excluded packagepackage0121-08250121-0825-08DDiscontinued by firm2026-08-03
excluded packagepackage0121-08250121-0825-15DDiscontinued by firm2026-08-03

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 · 6 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 packagepackage0121-0825-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-0825-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-0825-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-0825-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-0825-01f5e01cc5f278…a2eaf40c39c3…

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

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
A206573-001MORPHINE SULFATEMORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-14
A206573-002MORPHINE SULFATEMORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206573-001AA
A206573-002AA

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 2 · 61 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2016-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2023-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2016-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2023-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2016-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2023-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2016-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2023-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2016-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2023-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2016-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2023-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2016-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORAL2023-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206573-002MORPHINE SULFATE10MG/5MLSOLUTION / ORALAA2023-09-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A206573-001MORPHINE SULFATE100MG/5MLSOLUTION / ORALAA2016-11-14b00525d2431f…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206573-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206573-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206573-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206573-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206573-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206573-002AA16a471c1ec25d…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206573-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206573-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206573-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206573-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206573-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206573-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206573-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206573-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206573-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206573-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206573-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206573-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206573-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206573-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206573-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A206573-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206573-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206573-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206573-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A206573-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206573-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206573-001AA16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206573-002AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206573-001AA11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206573-002AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206573-001AA1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A206573-002AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206573-001AA1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206573-002AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206573-001AA19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206573-002AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206573-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206573-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206573-001AA1053a50430f4f…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0825-01ML - Milliliter0121-0825693f0af6-6fb1-4a4b-9122-ac37a8ad218d12018-08-13
0121-0825-04ML - Milliliter0121-0825a6a6ba1c-0861-4fd4-bfde-0fc0c088f5f012018-08-13
0121-0825-08ML - Milliliter0121-0825c3beaf40-13cd-45e7-b5e7-3494138fa57b12022-05-04
0121-0825-15ML - Milliliter0121-0825318c5011-6a19-4fde-b178-d3f8c9d1c39c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0825MORPHINE SULFATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]17Legacy NDC20250507_9405556c-20e0-4e47-b1b0-7872bcc6517e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATEAmerican Health Packaging66a3f607-7f48-490f-84dd-b74dd1ee39e52026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206573
application number: ANDA206573
Morphine SulfateMORPHINE SULFATEPAI Holdings, LLC dba PAI Pharma9405556c-20e0-4e47-b1b0-7872bcc6517e2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206573
application number: ANDA206573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0825-010012108250130 mL in 1 BOTTLE (0121-0825-01) 30 ml2016-11-140000-00-00NoNoCurrent
0121-0825-0400121082504118 mL in 1 BOTTLE (0121-0825-04) 118 ml2016-11-140000-00-00NoNoCurrent
0121-0825-0800121082508240 mL in 1 BOTTLE (0121-0825-08) 240 ml2016-11-140000-00-00NoNoCurrent
0121-0825-15001210825151 BOTTLE in 1 CARTON (0121-0825-15) > 15 mL in 1 BOTTLE1 bottle2022-10-120000-00-00NoNoCurrent