Home NDC 0264-7578 Mannitol
Product NDC 0264-7578
11-digit product format 002647578
Labeler code 0264
Product ID 0264-7578_33171b62-3532-4eb1-b273-714d07b0e3f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MANNITOL
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA020006
Marketing category NDA
Marketing start 1993-07-26
Substance MANNITOL
Active strength 20 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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020006-001 MANNITOL 5% IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 2026-09-14 22:38:34 2026-08 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020006-001 MANNITOL 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP 1993-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020006-002 MANNITOL 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 1993-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020006-003 MANNITOL 15% IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP 1993-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020006-004 MANNITOL 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP 1993-07-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mannitol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MANNITOL 20 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791403 Internal RxNorm lookup 1791408 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0264-7578-10 Mannitol 500 mL in 1 CONTAINER INJECTION, SOLUTION 500 21 0264-7578-10 Mannitol 24 in 1 CASE INJECTION, SOLUTION 24 21 0264-7578-20 Mannitol 250 mL in 1 CONTAINER INJECTION, SOLUTION 250 21 0264-7578-20 Mannitol 24 in 1 CASE INJECTION, SOLUTION 24 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-7578 MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 21 Current NDC, Legacy NDC, 4 package rows 20230824_d12cc802-b538-4065-a264-f474ff3b3043.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 0264-7578-10 00264757810 24 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINER 24 container 1993-07-26 0000-00-00 No No Current 0264-7578-20 00264757820 24 CONTAINER in 1 CASE (0264-7578-20) / 250 mL in 1 CONTAINER 24 container 1993-07-26 0000-00-00 No No Current