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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
MANNITOL	20 g/100mL

Field, Values table
Field	Values
Unii	3OWL53L36A
Rxcui	1791403, 1791408

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-7578-10	ML - Milliliter	0264-7578	293b9f64-ed42-4aa6-ab91-2a0c3416fdef	1	2012-07-24
0264-7578-20	ML - Milliliter	0264-7578	f1121df2-4ed9-44f1-97d4-ebd74ed9a114	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MANNITOL	ACTIVE INGREDIENT	3OWL53L36A	MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	6
MANNITOL	ACTIVE MOIETY	3OWL53L36A	MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	6

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3OWL53L36A	MANNITOL	69-65-8	MANNITOL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791403	mannitol 20 % in 250 ML Injection	PSN	d12cc802-b538-4065-a264-f474ff3b3043	21
1791408	mannitol 20 % in 500 ML Injection	PSN	d12cc802-b538-4065-a264-f474ff3b3043	21
1791403	250 ML mannitol 200 MG/ML Injection	SCD	d12cc802-b538-4065-a264-f474ff3b3043	21
1791408	500 ML mannitol 200 MG/ML Injection	SCD	d12cc802-b538-4065-a264-f474ff3b3043	21
1791403	mannitol 20 % per 250 ML Injection	SY	d12cc802-b538-4065-a264-f474ff3b3043	21
1791408	mannitol 20 % per 500 ML Injection	SY	d12cc802-b538-4065-a264-f474ff3b3043	21

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