Mannitol
- Product NDC
- 52584-031
- Requested package NDC
- 52584-031-01
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 52584-031 | 52584-031-01 | D | Discontinued by firm | 2026-09-14 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016269-001 | MANNITOL 5% | 5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-002 | MANNITOL 10% | 10GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-003 | MANNITOL 15% | 15GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-004 | MANNITOL 20% | 20GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-005 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016269-006 | MANNITOL 25% | 12.5GM/50ML | INJECTABLE / INJECTION | AP | 1994-08-25 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016269-006 | AP | 1 | 84e616aacf4f… |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
| 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.
| 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 | 016269 NDA016269 |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 016269 NDA016269 |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 016269 NDA016269 |
Packages#
| 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 |