Mannitol

Product NDC: 0264-7578
11-digit product format: 002647578
Labeler code: 0264
Product ID: 0264-7578_33171b62-3532-4eb1-b273-714d07b0e3f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MANNITOL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: B. Braun Medical Inc.
Application: NDA020006
Marketing category: NDA
Marketing start: 1993-07-26
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	MANNITOL	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26
N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	MANNITOL	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26
N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	MANNITOL	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26
N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	MANNITOL	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N020006-001	AP
N020006-002	AP
N020006-003	AP
N020006-004	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 · 168 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
2026-08-18 06:07:40	2026-07	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-001	MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-002	MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-003	MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-004	MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	INJECTABLE / INJECTION	AP	1993-07-26	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020006-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020006-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020006-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020006-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020006-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020006-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020006-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020006-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020006-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020006-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020006-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020006-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020006-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020006-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020006-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020006-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020006-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020006-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020006-004	AP	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mannitol
Listing expiration: 2026-12-31

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
d12cc802-b538-4065-a264-f474ff3b3043	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0264-7578-10	Mannitol	500 mL in 1 CONTAINER	INJECTION, SOLUTION	500	21
0264-7578-10	Mannitol	24 in 1 CASE	INJECTION, SOLUTION	24	21
0264-7578-20	Mannitol	250 mL in 1 CONTAINER	INJECTION, SOLUTION	250	21
0264-7578-20	Mannitol	24 in 1 CASE	INJECTION, SOLUTION	24	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-7578-10	ML - Milliliter	0264-7578	293b9f64-ed42-4aa6-ab91-2a0c3416fdef	1	2012-07-24
0264-7578-20	ML - Milliliter	0264-7578	f1121df2-4ed9-44f1-97d4-ebd74ed9a114	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MANNITOL	ACTIVE INGREDIENT	3OWL53L36A	MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	6
MANNITOL	ACTIVE MOIETY	3OWL53L36A	MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0264-7578	MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	21	Current NDC, Legacy NDC, 4 package rows	20230824_d12cc802-b538-4065-a264-f474ff3b3043.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	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020006 application number: NDA020006 ndc (product): 0264-7578

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	d12cc802-b538-4065-a264-f474ff3b3043	21
1791408	mannitol 20 % in 500 ML Injection	PSN	d12cc802-b538-4065-a264-f474ff3b3043	21
1791403	250 ML mannitol 200 MG/ML Injection	SCD	d12cc802-b538-4065-a264-f474ff3b3043	21
1791408	500 ML mannitol 200 MG/ML Injection	SCD	d12cc802-b538-4065-a264-f474ff3b3043	21
1791403	mannitol 20 % per 250 ML Injection	SY	d12cc802-b538-4065-a264-f474ff3b3043	21
1791408	mannitol 20 % per 500 ML Injection	SY	d12cc802-b538-4065-a264-f474ff3b3043	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0264-7578-10	00264757810	24 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINER	24 container	1993-07-26	0000-00-00	No	No	Current
0264-7578-20	00264757820	24 CONTAINER in 1 CASE (0264-7578-20) / 250 mL in 1 CONTAINER	24 container	1993-07-26	0000-00-00	No	No	Current