Home NDC 0338-0353-03 Osmitrol
Product NDC 0338-0353
Requested package NDC 0338-0353-03
11-digit product format 003380353
Labeler code 0338
Product ID 0338-0353_3911fd42-2b73-4509-9c4c-92ceba4e6d34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mannitol
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Company
Application NDA013684
Marketing category NDA
Marketing start 1964-06-08
Substance MANNITOL
Active strength 10 g/100mL
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 1 .
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 · 328 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 2026-02-19 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…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 328 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Osmitrol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MANNITOL 10 g/100mL
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 206536 Internal RxNorm lookup 1791395 Internal RxNorm lookup 1791403 Internal RxNorm lookup 1791404 Internal RxNorm lookup 1791408 Internal RxNorm lookup 1791409 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0353-03 Osmitrol 500 mL in 1 BAG INJECTION, SOLUTION 500 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0353 OSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] 14 Current NDC, Legacy NDC, 1 package rows 20250519_0d914965-7001-45cb-ba51-d7c5964b05bc.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-0353-03 00338035303 500 mL in 1 BAG (0338-0353-03) 500 ml 1964-06-08 0000-00-00 No No Current