SODIUM BICARBONATE

Product NDC
83854-001
11-digit product format
838540001
Labeler code
83854
Product ID
83854-001_38887da2-9f53-8db2-e063-6294a90a7738
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Anthea Pharma Private Limited
Application
ANDA219701
Marketing category
ANDA
Marketing start
2025-06-26
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
83854-001-20SODIUM BICARBONATE20 in 1 CARTONINJECTION, SOLUTION203
83854-001-20SODIUM BICARBONATE50 mL in 1 VIALINJECTION, SOLUTION503
83854-001-25SODIUM BICARBONATE25 in 1 CARTONINJECTION, SOLUTION253
83854-001-25SODIUM BICARBONATE50 mL in 1 VIALINJECTION, SOLUTION503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN0df8cf62-4b49-4ec4-aae4-c4a3e6d765493
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD0df8cf62-4b49-4ec4-aae4-c4a3e6d765493
186848650 ML NaHCO3 84 MG/ML InjectionSY0df8cf62-4b49-4ec4-aae4-c4a3e6d765493
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY0df8cf62-4b49-4ec4-aae4-c4a3e6d765493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83854-001-208385400012020 VIAL in 1 CARTON (83854-001-20) / 50 mL in 1 VIAL20 vial2025-06-26NoNoCurrent
83854-001-258385400012525 VIAL in 1 CARTON (83854-001-25) / 50 mL in 1 VIAL25 vial2025-06-26NoNoCurrent