Mannitol

Product NDC: 52584-031
11-digit product format: 525840031
Labeler code: 52584
Product ID: 52584-031_23fbdef9-7b67-431e-80e7-0bc781e38975
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mannitol
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: General Injectables & Vaccines, Inc
Application: NDA016269
Marketing category: NDA
Marketing start: 2019-11-19
Marketing end: 2023-12-01
Substance: MANNITOL
Active strength: 13 g/50mL
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 product	product	52584-031		D	Discontinued by firm		2026-08-17
excluded package	package	52584-031	52584-031-01	D	Discontinued by firm		2026-08-17

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-031-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-031-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-031-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-031-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-031-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-031-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-031-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-031-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-031-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-031-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-031-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-031-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Mannitol	ACTIVE INGREDIENT	3OWL53L36A	MANNITOL INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	3
Mannitol	ACTIVE MOIETY	3OWL53L36A	MANNITOL INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	3

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-031-01	52584003101	1 VIAL, SINGLE-DOSE in 1 BAG (52584-031-01) > 50 mL in 1 VIAL, SINGLE-DOSE	2019-11-19	2023-12-01	No	No	Current