FDA.reportPublic FDA data

SODIUM BICARBONATE

Product NDC
81298-7620
11-digit product format
812987620
Labeler code
81298
Product ID
81298-7620_1a255946-a137-4e13-8203-65dd80b34872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium bicarbonate injection,
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Long Grove Pharmaceuticals, LLC
Application
ANDA216042
Marketing category
ANDA
Marketing start
2024-09-30
Substance
SODIUM BICARBONATE
Active strength
84 mg/mL
Pharmacologic classes
Alkalinizing Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM BICARBONATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE84 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MDF5V39QO
Rxcui1868486

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81298-7620-1SODIUM BICARBONATE50 mL in 1 VIALSOLUTION502
81298-7620-3SODIUM BICARBONATE20 in 1 CARTONSOLUTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81298-7620-1ML - Milliliter81298-762054fece53-779f-41ac-83ba-8c56c6f7c07e12024-10-04
81298-7620-3ML - Milliliter81298-7620f5c504f7-b9a3-4c31-9c3c-19b1e8f85bf212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81298-7620SODIUM BICARBONATE (SODIUM BICARBONATE INJECTION,) SOLUTION [LONG GROVE PHARMACEUTICALS, LLC ]2Current NDC, 2 package rows20241001_a26d709b-b294-4b02-9a88-7e840f099a33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNa26d709b-b294-4b02-9a88-7e840f099a332
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDa26d709b-b294-4b02-9a88-7e840f099a332
186848650 ML NaHCO3 84 MG/ML InjectionSYa26d709b-b294-4b02-9a88-7e840f099a332
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYa26d709b-b294-4b02-9a88-7e840f099a332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81298-7620-18129876200150 mL in 1 VIAL50 mlHistorical
81298-7620-38129876200320 VIAL in 1 CARTON (81298-7620-3) / 50 mL in 1 VIAL (81298-7620-1) 20 vial2024-09-30NoNoCurrent