Home NDC 0338-0351 Osmitrol
Product NDC 0338-0351
11-digit product format 003380351
Labeler code 0338
Product ID 0338-0351_b7ee8a9b-2590-4017-a35c-18df36790502
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mannitol
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA013684
Marketing category NDA
Marketing start 1964-06-08
Marketing end 0000-00-00
Substance MANNITOL
Active strength 5 g/100mL
Pharmacologic classes Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 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 0338-0351-04 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N013684-001 OSMITROL 5% IN WATER MANNITOL 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-002 OSMITROL 10% IN WATER MANNITOL 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-003 OSMITROL 20% IN WATER MANNITOL 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-004 OSMITROL 15% IN WATER MANNITOL 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 matching rows.
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 9 · 336 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 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 336 observed states.
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 Osmitrol MANNITOL Baxter Healthcare Company 0d914965-7001-45cb-ba51-d7c5964b05bc 2025-08-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 013684 application number: NDA013684