Mannitol

Product NDC: 0409-7715
Requested package NDC: 0409-7715-03
11-digit product format: 004097715
Labeler code: 0409
Product ID: 0409-7715_35c2d78f-a95c-4619-aff2-82ea456f7759
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MANNITOL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA019603
Marketing category: NDA
Marketing start: 2005-09-19
Marketing end: 2021-12-08
Substance: MANNITOL
Active strength: 20 g/100mL
Pharmacologic classes: Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0409-7715	0409-7715-03	D	Discontinued by firm		2026-09-14
excluded package	package	0409-7715	0409-7715-03	D	Discontinued by firm		2026-09-14

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 · 24 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…`
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	MANNITOL	5GM/100ML	INJECTABLE / INJECTION		1987-01-08
N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	MANNITOL	10GM/100ML	INJECTABLE / INJECTION		1987-01-08
N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	MANNITOL	15GM/100ML	INJECTABLE / INJECTION		1990-01-08
N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	MANNITOL	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019603-004	AP

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION		1987-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION		1987-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION		1990-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1990-01-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019603-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019603-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019603-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019603-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019603-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019603-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019603-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019603-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019603-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019603-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019603-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019603-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019603-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019603-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019603-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019603-004	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019603-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019603-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019603-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019603-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019603-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019603-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019603-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019603-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019603-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019603-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019603-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019603-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019603-004	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019603-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019603-004	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019603-004	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019603-004	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019603-004	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019603-004	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019603-004	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019603-004	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019603-004	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019603-004	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019603-004	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-7715-02	ML - Milliliter	0409-7715	cc6439ce-9931-4d01-a954-14dd5a314e25	1	2012-07-24
0409-7715-03	ML - Milliliter	0409-7715	20fd32e1-b63a-440c-80ec-cb4e8e1b1934	1	2012-07-24
0409-7715-12	ML - Milliliter	0409-7715	8e2451bc-b147-408a-aab4-c21fa5432338	1	2017-07-07
0409-7715-13	ML - Milliliter	0409-7715	677217e9-1440-4b55-94fc-02a620492001	1	2017-06-15

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mannitol	MANNITOL	ICU Medical Inc.	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019603 application number: NDA019603

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3OWL53L36A	MANNITOL	69-65-8	MANNITOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-7715-03	00409771503	12 POUCH in 1 CASE (0409-7715-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG (0409-7715-13)	12 pouch	2005-09-19	2021-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mannitol Intravenous Mannitol Injection, USP Flexible Plastic Container	Hospira, Inc.	2020-07-14	HUMAN PRESCRIPTION DRUG LABEL	7