Mannitol

Product NDC: 0990-7715
11-digit product format: 009907715
Labeler code: 0990
Product ID: 0990-7715_2a3b6672-1d54-4049-b090-de3776cbb6ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MANNITOL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: ICU Medical Inc.
Application: NDA019603
Marketing category: NDA
Marketing start: 2019-05-31
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: 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 · 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.

Additional Listing Data#

Finished product: Yes
Brand name base: Mannitol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MANNITOL	20 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3OWL53L36A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1791403	Internal RxNorm lookup
1791408	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
ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0990-7715-02	Mannitol	24 in 1 CASE	INJECTION, SOLUTION	24	5
0990-7715-02	Mannitol	1 in 1 POUCH	INJECTION, SOLUTION	1	5
0990-7715-03	Mannitol	12 in 1 CASE	INJECTION, SOLUTION	12	5
0990-7715-03	Mannitol	1 in 1 POUCH	INJECTION, SOLUTION	1	5
0990-7715-12	Mannitol	250 mL in 1 BAG	INJECTION, SOLUTION	250	5
0990-7715-13	Mannitol	500 mL in 1 BAG	INJECTION, SOLUTION	500	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0990-7715-03	ML - Milliliter	0990-7715	f898ab0f-90a1-4d72-8c81-93021b05aa7f	1	2020-01-03
0990-7715-13	ML - Milliliter	0990-7715	5f29eccf-1abd-4b29-ad95-9312f38b466d	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0990-7715	MANNITOL INJECTION, SOLUTION [ICU MEDICAL INC.]	4	Current NDC, Legacy NDC, 6 package rows	20221208_ba7bf864-8a4d-4262-8fd1-00174fa2f9d1.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 · 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 ndc (product): 0990-7715

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791403	mannitol 20 % in 250 ML Injection	PSN	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	5
1791408	mannitol 20 % in 500 ML Injection	PSN	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	5
1791403	250 ML mannitol 200 MG/ML Injection	SCD	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	5
1791408	500 ML mannitol 200 MG/ML Injection	SCD	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	5
1791403	mannitol 20 % per 250 ML Injection	SY	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	5
1791408	mannitol 20 % per 500 ML Injection	SY	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0990-7715-02	00990771502	24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12)	24 pouch	2019-08-01	0000-00-00	No	No	Current
0990-7715-03	00990771503	12 POUCH in 1 CASE (0990-7715-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13)	12 pouch	2019-05-31	0000-00-00	No	No	Current
0990-7715-12	00990771512	250 mL in 1 BAG	250 ml					Historical
0990-7715-13	00990771513	500 mL in 1 BAG	500 ml					Historical