Application 019916

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	1MG/ML	Yes	Yes
002	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	5MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019916-001	MORPHINE SULFATE	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30
N019916-002	MORPHINE SULFATE	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27

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 · 86 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
2026-09-14 22:38:34	2026-08	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019916-001	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1992-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019916-002	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2006-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019916-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION		RLD	1992-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019916-002	MORPHINE SULFATE	5MG/ML	INJECTABLE / INJECTION		RLD	2006-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019916-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION		RLD	1992-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019916-002	MORPHINE SULFATE	5MG/ML	INJECTABLE / INJECTION		RLD	2006-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019916-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019916-002	MORPHINE SULFATE	5MG/ML	INJECTABLE / INJECTION		RLD	2006-10-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019916-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019916-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019916-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019916-001	AP	1	`ea99ee380514…`

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 2 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	5422cdac-8073-41fc-8665-ffe9797f5c02	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	1d181906-f3ec-4222-1883-e61577a3122e	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	2dd52157-3121-41ed-abc2-99b269531e56	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MORPHINE SULFATE generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	c94d9da6-7a12-44ee-a38f-3323ee27842c	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate ER	MORPHINE SULFATE	Bryant Ranch Prepack	872ceecb-1f14-7a43-7451-e4650a01fbd9	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	cc3b491c-a206-3027-54f0-f87c0dd40a7f	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Sun Pharmaceutical Industries, Inc.	736c9b80-682c-4cda-bf18-61b18de0bd39	2026-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Actavis Pharma, Inc.	2da87bfa-11fd-43e3-8fef-d16ebeb15680	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
MITIGO	MORPHINE SULFATE	Piramal Critical Care, Inc.	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Cranbury Pharmaceuticals, LLC	d8598654-94ad-4cfb-81d2-9b68e013a428	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	07993f6c-146b-4728-a2da-6e93089f78ff	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	66a3f607-7f48-490f-84dd-b74dd1ee39e5	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ca359246-4674-4b32-b8b2-673d32b7112f	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	3c847554-3b4b-4d24-a145-2ef7e9b83699	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	9405556c-20e0-4e47-b1b0-7872bcc6517e	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	be420e8b-bcb0-49b5-bb4d-1df8b9959809	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	ee8057d1-ed12-4e18-9efa-d83504abf612	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Duramorph	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ebb18761-e5c4-4238-bb84-f9549f500210	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-2029	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-2029	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-6028	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
70518-1107	Morphine Sulfate	MORPHINE SULFATE	REMEDYREPACK INC.	NDA	Current
70518-1107	Morphine Sulfate	MORPHINE SULFATE	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60473	SUPPL	2019-10-09
60275	SUPPL	2019-10-07
46388	SUPPL	2016-12-21
46387	SUPPL	2016-12-21
46245	SUPPL	2016-12-20
46244	SUPPL	2016-12-20
19844	SUPPL	2006-11-06
11850	SUPPL	2006-11-06