Sodium Bicarbonate

Product NDC
70518-4158
11-digit product format
705184158
Labeler code
70518
Product ID
70518-4158_3fb730ba-82fd-149f-e063-6394a90afa94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA203449
Marketing category
ANDA
Marketing start
2024-08-14
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
Rxcui792582

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
70518-4158-0Sodium Bicarbonate50 mL in 1 SYRINGEINJECTION504
70518-4158-0Sodium Bicarbonate1 in 1 CARTONINJECTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4158SODIUM BICARBONATE INJECTION [REMEDYREPACK INC.]3Current NDC, 2 package rows20250418_96093b76-5d98-4d2b-b851-20207a8864db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
792582sodium bicarbonate 8.4 % (50 MEQ) in 50 ML Prefilled SyringePSN96093b76-5d98-4d2b-b851-20207a8864db4
79258250 ML sodium bicarbonate 84 MG/ML Prefilled SyringeSCD96093b76-5d98-4d2b-b851-20207a8864db4
79258250 ML NaHCO3 84 MG/ML Prefilled SyringeSY96093b76-5d98-4d2b-b851-20207a8864db4
792582sodium bicarbonate 8.4 % (50 MEQ) per 50 ML Prefilled SyringeSY96093b76-5d98-4d2b-b851-20207a8864db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4158-0705184158001 SYRINGE in 1 CARTON (70518-4158-0) / 50 mL in 1 SYRINGE1 syringe2024-08-14NoNoCurrent