Home NDC 0054-0238 Morphine Sulfate
Product NDC 0054-0238
11-digit product format 000540238
Labeler code 0054
Product ID 0054-0238_1bfdbb7c-d06a-4010-82f9-189b59a2f18d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA022195
Marketing category NDA
Marketing start 2008-03-17
Substance MORPHINE SULFATE
Active strength 20 mg/5mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022195-001 MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 N022195-002 MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 N022195-003 MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL RLD 2008-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022195-002 MORPHINE SULFATE 20MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022195-003 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022195-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA RLD 2008-03-17 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 125 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Morphine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MORPHINE SULFATE 20 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X3P646A2J0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 892589 Internal RxNorm lookup 892625 Internal RxNorm lookup 894780 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0238-49 Morphine Sulfate 100 mL in 1 BOTTLE SOLUTION 100 4 0054-0238-63 Morphine Sulfate 500 mL in 1 BOTTLE SOLUTION 500 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 SORBITOL INACTIVE INGREDIENT 506T60A25R MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14 WATER INACTIVE INGREDIENT 059QF0KO0R MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0238 MORPHINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231223_ca359246-4674-4b32-b8b2-673d32b7112f.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Morphine Sulfate MORPHINE SULFATE Precision Dose, Inc. 6654b91e-3b3f-4062-ac65-a2a70f942da4 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022195 application number: NDA022195 Morphine Sulfate MORPHINE SULFATE Precision Dose Inc. 8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc 2026-05-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022195 application number: NDA022195 Morphine Sulfate MORPHINE SULFATE Hikma Pharmaceuticals USA Inc. ca359246-4674-4b32-b8b2-673d32b7112f 2026-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022195 application number: NDA022195 ndc (product): 0054-0238 Morphine Sulfate MORPHINE SULFATE American Health Packaging 9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb 2025-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022195 application number: NDA022195 Morphine Sulfate MORPHINE SULFATE PAI Holdings, LLC dba PAI Pharma 6e32b869-31c7-48c1-98ae-b21bd28151d7 2024-11-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022195 application number: NDA022195
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0238-49 00054023849 100 mL in 1 BOTTLE (0054-0238-49) 100 ml 2008-03-17 0000-00-00 No No Current 0054-0238-63 00054023863 500 mL in 1 BOTTLE (0054-0238-63) 500 ml 2008-03-17 0000-00-00 No No Current