Mannitol

Product NDC: 0404-9905
11-digit product format: 004049905
Labeler code: 0404
Product ID: 0404-9905_f3bb5de6-286d-4efc-a55d-e0b65dc4b1c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mannitol
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: NDA016269
Marketing category: NDA
Marketing start: 2022-01-12
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: 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 · 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: 2026-12-31

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
e2444db1-9dfe-451f-a33c-9b00786464d2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9905-50	Mannitol	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	50		6
0404-9905-50	Mannitol	1 in 1 BAG	INJECTION, SOLUTION	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9905	MANNITOL INJECTION, SOLUTION [HENRY SCHEIN, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250522_e2444db1-9dfe-451f-a33c-9b00786464d2.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
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 ndc (product): 0404-9905
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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9905-50	00404990550	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE	2022-01-12	0000-00-00	No	No	Current