Home NDC 63629-4175 Morphine Sulfate
Product NDC 63629-4175
11-digit product format 636294175
Labeler code 63629
Product ID 63629-4175_3f3a870e-f325-475b-8453-fe3d1bb8f54a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA022207
Marketing category NDA
Marketing start 2008-03-17
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 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 · 104 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022207-001 MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 N022207-002 MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-4175-1 2020-10-16 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-2 2020-10-16 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-3 2020-10-16 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-4 2020-10-16 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-5 2020-10-16 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-6 2020-10-16 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-7 2020-10-16 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-1 2020-01-31 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-2 2020-01-31 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-3 2020-01-31 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-4 2020-01-31 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-5 2020-01-31 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-6 2020-01-31 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941 63629-4175-7 2020-01-31 These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate tablets, for oral use CII Initial U.S. Approval: 1941
DailyMed Socrata Ingredients# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Morphine Sulfate MORPHINE SULFATE Hikma Pharmaceuticals USA Inc. 3c847554-3b4b-4d24-a145-2ef7e9b83699 2026-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022207 application number: NDA022207
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-4175-1 63629417501 60 TABLET in 1 BOTTLE (63629-4175-1) 60 tablet 2010-03-19 0000-00-00 No No Current 63629-4175-2 63629417502 90 TABLET in 1 BOTTLE (63629-4175-2) 90 tablet 2010-03-26 0000-00-00 No No Current 63629-4175-3 63629417503 30 TABLET in 1 BOTTLE (63629-4175-3) 30 tablet 2011-06-14 0000-00-00 No No Current 63629-4175-4 63629417504 120 TABLET in 1 BOTTLE (63629-4175-4) 120 tablet 2012-08-09 0000-00-00 No No Current 63629-4175-5 63629417505 45 TABLET in 1 BOTTLE (63629-4175-5) 45 tablet 2013-06-26 0000-00-00 No No Current 63629-4175-6 63629417506 15 TABLET in 1 BOTTLE (63629-4175-6) 15 tablet 2021-12-22 0000-00-00 No No Current 63629-4175-7 63629417507 20 TABLET in 1 BOTTLE (63629-4175-7) 20 tablet 2021-12-22 0000-00-00 No No Current