Home NDC 0527-1425 Morphine Sulfate
Product NDC 0527-1425
11-digit product format 005271425
Labeler code 0527
Product ID 0527-1425_03e46aa8-77bf-4e1c-9c3f-cb307937b493
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Lannett Company, Inc.
Application NDA201517
Marketing category NDA
Marketing start 2011-06-23
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 2019-12-31
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 · 85 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201517-001 MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N201517-001 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL 2011-06-23 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0527-1425-35 2022-06-01 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941 0527-1425-36 2022-06-01 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941 0527-1425-62 2022-06-01 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941 0527-1425-63 2022-06-01 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941 0527-1425-35 2020-01-31 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941 0527-1425-36 2020-01-31 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941 0527-1425-62 2020-01-31 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941 0527-1425-63 2020-01-31 These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 SORBITOL INACTIVE INGREDIENT 506T60A25R MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19 WATER INACTIVE INGREDIENT 059QF0KO0R MORPHINE SULFATE SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 19