Mannitol

Product NDC: 0409-4031
11-digit product format: 004094031
Labeler code: 0409
Product ID: 0409-4031_4092b5ac-45f3-4404-a790-c190eb8a3545
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MANNITOL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA016269
Marketing category: NDA
Marketing start: 2004-11-30
Substance: MANNITOL
Active strength: 12.5 g/50mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016269-001	MANNITOL 5%	MANNITOL	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-002	MANNITOL 10%	MANNITOL	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-003	MANNITOL 15%	MANNITOL	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-004	MANNITOL 20%	MANNITOL	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-005	MANNITOL 25%	MANNITOL	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982
N016269-006	MANNITOL 25%	MANNITOL	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016269-006	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 7 · 252 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
2026-08-18 06:07:40	2026-07	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N016269-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016269-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016269-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016269-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016269-006	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016269-006	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016269-006	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016269-006	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016269-006	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016269-006	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016269-006	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016269-006	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016269-006	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016269-006	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016269-006	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016269-006	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016269-006	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016269-006	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016269-006	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016269-006	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016269-006	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016269-006	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016269-006	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016269-006	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016269-006	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016269-006	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016269-006	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016269-006	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016269-006	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016269-006	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016269-006	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016269-006	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016269-006	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016269-006	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016269-006	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016269-006	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MANNITOL	12.5 g/50mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311450	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
8ad3145e-00e7-4412-b9a5-06f00f264f30	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	Strength	SPL version
0409-4031-01	Mannitol	25 in 1 TRAY	INJECTION, SOLUTION	25		23
0409-4031-16	Mannitol	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	50		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-4031-01	ML - Milliliter	0409-4031	b51ff002-9034-4202-9bc3-f067cd7cd2a6	1	2012-07-24
0409-4031-16	ML - Milliliter	0409-4031	ad330647-8ea4-4886-801f-91f79e67ab20	1	2016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MANNITOL	ACTIVE INGREDIENT	3OWL53L36A	MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]	12
MANNITOL	ACTIVE MOIETY	3OWL53L36A	MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]	12
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]	12
Mannitol	ACTIVE INGREDIENT	3OWL53L36A	MANNITOL INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	3
Mannitol	ACTIVE MOIETY	3OWL53L36A	MANNITOL INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-4031	MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]	22	Current NDC, Legacy NDC, 2 package rows	20241129_8ad3145e-00e7-4412-b9a5-06f00f264f30.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mannitol	MANNITOL	Hospira, Inc.	8ad3145e-00e7-4412-b9a5-06f00f264f30	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016269 application number: NDA016269 ndc (product): 0409-4031
Mannitol	MANNITOL	Henry Schein, Inc.	e2444db1-9dfe-451f-a33c-9b00786464d2	2025-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016269 application number: NDA016269
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016269 application number: NDA016269

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
311450	mannitol 25 % in 50 ML Injection	PSN	8ad3145e-00e7-4412-b9a5-06f00f264f30	23
311450	50 ML mannitol 250 MG/ML Injection	SCD	8ad3145e-00e7-4412-b9a5-06f00f264f30	23
311450	mannitol 12.5 GM per 50 ML Injection	SY	8ad3145e-00e7-4412-b9a5-06f00f264f30	23
311450	mannitol 25 % per 50 ML Injection	SY	8ad3145e-00e7-4412-b9a5-06f00f264f30	23
311450	mannitol 25 % in 50 ML Injection	PSN	e2444db1-9dfe-451f-a33c-9b00786464d2	6
311450	50 ML mannitol 250 MG/ML Injection	SCD	e2444db1-9dfe-451f-a33c-9b00786464d2	6
311450	mannitol 12.5 GM per 50 ML Injection	SY	e2444db1-9dfe-451f-a33c-9b00786464d2	6
311450	mannitol 25 % per 50 ML Injection	SY	e2444db1-9dfe-451f-a33c-9b00786464d2	6
311450	mannitol 25 % in 50 ML Injection	PSN	999ce711-2d5b-0d7d-e053-2995a90a2689	4
311450	50 ML mannitol 250 MG/ML Injection	SCD	999ce711-2d5b-0d7d-e053-2995a90a2689	4
311450	mannitol 12.5 GM per 50 ML Injection	SY	999ce711-2d5b-0d7d-e053-2995a90a2689	4
311450	mannitol 25 % per 50 ML Injection	SY	999ce711-2d5b-0d7d-e053-2995a90a2689	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-4031-01	00409403101	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)		2004-11-30	0000-00-00	No	No	Current
0409-4031-16	00409403116	50 mL in 1 VIAL, SINGLE-DOSE	50 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mannitol	Hospira, Inc.	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	23
Mannitol	Henry Schein, Inc.	2025-05-20	HUMAN PRESCRIPTION DRUG LABEL	6
25% MANNITOL INJECTION, USP 12.5g/50mL (250mg/mL) 50mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-27	HUMAN PRESCRIPTION DRUG LABEL	4
Mannitol	General Injectables & Vaccines, Inc	2022-12-27	HUMAN PRESCRIPTION DRUG LABEL	13