Morphine Sulfate

Product NDC: 76045-238
11-digit product format: 760450238
Labeler code: 76045
Product ID: 76045-238_e61f6eb4-cc71-47d3-b2f6-5e689c773779
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: 2013-10-30
Substance: MORPHINE SULFATE
Active strength: 1 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 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	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

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204223-001	9072781	2034-03-12		Drug product	2015-07-13
N204223-001	9192608	2034-03-12	U-43		2015-12-04
N204223-001	9192608	2034-03-12	U-55		2015-12-04
N204223-001	9248229	2034-03-12		Drug product	2016-02-17
N204223-002	9072781	2034-03-12		Drug product	2015-07-13
N204223-002	9192608	2034-03-12	U-43		2015-12-04
N204223-002	9192608	2034-03-12	U-55		2015-12-04
N204223-002	9248229	2034-03-12		Drug product	2016-02-17
N204223-003	9072781	2034-03-12		Drug product	2015-07-13
N204223-003	9192608	2034-03-12	U-43		2015-12-04
N204223-003	9192608	2034-03-12	U-55		2015-12-04
N204223-003	9248229	2034-03-12		Drug product	2016-02-17
N204223-004	9072781	2034-03-12		Drug product	2015-07-13
N204223-004	9192608	2034-03-12	U-43		2015-12-04
N204223-004	9192608	2034-03-12	U-55		2015-12-04
N204223-004	9248229	2034-03-12		Drug product	2016-02-17
N204223-005	9072781	2034-03-12		Drug product	2015-07-13
N204223-005	9192608	2034-03-12	U-43		2015-12-04
N204223-005	9192608	2034-03-12	U-55		2015-12-04
N204223-005	9248229	2034-03-12		Drug product	2016-02-17

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 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 860 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204223-001	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-001	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-001	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-001	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204223-001	9072781	2034-03-12		Drug product	2015-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-001	9192608	2034-03-12	U-43		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-001	9192608	2034-03-12	U-55		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-001	9248229	2034-03-12		Drug product	2016-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-002	9072781	2034-03-12		Drug product	2015-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-002	9192608	2034-03-12	U-43		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-002	9192608	2034-03-12	U-55		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-002	9248229	2034-03-12		Drug product	2016-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-003	9072781	2034-03-12		Drug product	2015-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-003	9192608	2034-03-12	U-55		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-003	9192608	2034-03-12	U-43		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-003	9248229	2034-03-12		Drug product	2016-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-004	9072781	2034-03-12		Drug product	2015-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-004	9192608	2034-03-12	U-43		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-004	9192608	2034-03-12	U-55		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-004	9248229	2034-03-12		Drug product	2016-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-005	9072781	2034-03-12		Drug product	2015-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-005	9192608	2034-03-12	U-55		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-005	9192608	2034-03-12	U-43		2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204223-005	9248229	2034-03-12		Drug product	2016-02-17	`caaa826d4ba7…`

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	1 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
894912	Internal RxNorm lookup
894914	Internal RxNorm lookup
998212	Internal RxNorm lookup
998213	Internal RxNorm lookup
1442790	Internal RxNorm lookup
2752697	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1f53de80-efc8-4930-b3e3-fba0d026af05	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
89941d4c-522d-cee0-b273-43cfa7ef6d35	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
f15f9e76-db42-8a50-218a-5ef5affa58da	Product name	4	20240216
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
944b0689-73f4-6a2f-c654-1180896353c0	Product name	4	20220210
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
67e166c6-23d4-4709-b77d-5ca6182dcae0	Product name	1	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
c573a64c-fe17-2eac-fbcb-788868b4ff6b	Product name	9	20180619
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
7c1819cf-69a0-41dc-aeaa-a820729bc959	Product name	1	20170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2e	Product name	5	20161114
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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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Fresenius Kabi, USA LLC	1f53de80-efc8-4930-b3e3-fba0d026af05	2026-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204223 application number: NDA204223 ndc (product): 76045-238
Morphine Sulfate	MORPHINE SULFATE	Fresenius Kabi USA, LLC	582f42e5-444e-4246-af8c-e7e28097c69a	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204223 application number: NDA204223

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X3P646A2J0	MORPHINE SULFATE	6211-15-0	MORPHINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
894912	morphine sulfate 10 MG in 1 ML Prefilled Syringe	PSN	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998212	morphine sulfate 2 MG in 1 ML Prefilled Syringe	PSN	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998213	morphine sulfate 4 MG in 1 ML Prefilled Syringe	PSN	1f53de80-efc8-4930-b3e3-fba0d026af05	7
1442790	morphine sulfate 5 MG in 1 ML Prefilled Syringe	PSN	1f53de80-efc8-4930-b3e3-fba0d026af05	7
894914	morphine sulfate 8 MG in 1 ML Prefilled Syringe	PSN	1f53de80-efc8-4930-b3e3-fba0d026af05	7
894912	1 ML morphine sulfate 10 MG/ML Prefilled Syringe	SCD	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998212	1 ML morphine sulfate 2 MG/ML Prefilled Syringe	SCD	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998213	1 ML morphine sulfate 4 MG/ML Prefilled Syringe	SCD	1f53de80-efc8-4930-b3e3-fba0d026af05	7
1442790	1 ML morphine sulfate 5 MG/ML Prefilled Syringe	SCD	1f53de80-efc8-4930-b3e3-fba0d026af05	7
894914	1 ML morphine sulfate 8 MG/ML Prefilled Syringe	SCD	1f53de80-efc8-4930-b3e3-fba0d026af05	7
894912	1 ML MS 10 MG/ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998212	1 ML MS 2 MG/ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998213	1 ML MS 4 MG/ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
1442790	1 ML MS 5 MG/ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
894914	1 ML MS 8 MG/ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
894912	morphine sulfate 10 MG per 1 ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998212	morphine sulfate 2 MG per 1 ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
998213	morphine sulfate 4 MG per 1 ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
1442790	morphine sulfate 5 MG per 1 ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7
894914	morphine sulfate 8 MG per 1 ML Prefilled Syringe	SY	1f53de80-efc8-4930-b3e3-fba0d026af05	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76045-238-10	76045023810	10 SYRINGE, GLASS in 1 CARTON (76045-238-10) / .5 mL in 1 SYRINGE, GLASS (76045-238-01)	2026-05-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Fresenius Kabi, USA LLC \| Fresenius Kabi USA, LLC	2026-08-31	HUMAN PRESCRIPTION DRUG LABEL	8