Home NDC 63323-458-01 Morphine Sulfate
Product NDC 63323-458
Requested package NDC 63323-458-01
11-digit product format 633230458
Labeler code 63323
Product ID 63323-458_f5584ff8-f338-4d14-b29e-e37b3978b747
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA204223
Marketing category NDA
Marketing start 2018-04-10
Substance MORPHINE SULFATE
Active strength 8 mg/mL
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
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204223-001 MORPHINE SULFATE MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 N204223-002 MORPHINE SULFATE MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 N204223-003 MORPHINE SULFATE MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 N204223-004 MORPHINE SULFATE MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 N204223-005 MORPHINE SULFATE MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 N204223-006 MORPHINE SULFATE MORPHINE SULFATE 1MG/0.5ML (1MG/0.5ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2026-05-29
Orange Book patents# Current patent rows page 1 of 1 · 20 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 6 · 221 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 2026-10-15 13:18:30 2026-09 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204223-005 MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204223-006 MORPHINE SULFATE 1MG/0.5ML (1MG/0.5ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2026-05-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204223-005 MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204223-005 MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204223-005 MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204223-005 MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204223-005 MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204223-005 MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204223-001 MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204223-002 MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD, RS 2013-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204223-003 MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204223-004 MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS RLD 2013-10-30 b8a1b40f171c…
Observed Orange Book patent history# Patent history page 1 of 22 · 880 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 8 mg/mL
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731993 Internal RxNorm lookup 1732006 Internal RxNorm lookup 1732011 Internal RxNorm lookup 1732136 Internal RxNorm lookup 2003714 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 63323-458-00 Morphine Sulfate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 6 63323-458-01 Morphine Sulfate 25 in 1 BOX INJECTION, SOLUTION 25 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-458 MORPHINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250321_582f42e5-444e-4246-af8c-e7e28097c69a.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63323-458-01 63323045801 25 VIAL, SINGLE-DOSE in 1 BOX (63323-458-01) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-458-00) 2018-04-10 0000-00-00 No No Current