FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
63323-083
11-digit product format
633230083
Labeler code
63323
Product ID
63323-083_9def795c-abcf-483c-8b1d-e4374666efb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA206688
Marketing category
ANDA
Marketing start
2025-08-25
Substance
SODIUM BICARBONATE
Active strength
42 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 BICARBONATE42 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MDF5V39QO
Rxcui1868469, 1868486

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
63323-083-03Sodium Bicarbonate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION58
63323-083-05Sodium Bicarbonate25 in 1 TRAYINJECTION, SOLUTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-083-03ML - Milliliter63323-0833a2d0686-6144-4421-b7fc-4cf87f4c3fc912025-10-14
63323-083-05ML - Milliliter63323-083e3870028-d1f2-406d-870d-bf0fa2262eb812017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-083SODIUM BICARBONATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20250322_0ab55004-bb63-436d-ad77-cd3796905370.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868469sodium bicarbonate 4.2 % (2.5 MEQ) in 5 ML InjectionPSN0ab55004-bb63-436d-ad77-cd37969053708
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN0ab55004-bb63-436d-ad77-cd37969053708
18684695 ML sodium bicarbonate 42 MG/ML InjectionSCD0ab55004-bb63-436d-ad77-cd37969053708
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD0ab55004-bb63-436d-ad77-cd37969053708
18684695 ML NaHCO3 42 MG/ML InjectionSY0ab55004-bb63-436d-ad77-cd37969053708
186848650 ML NaHCO3 84 MG/ML InjectionSY0ab55004-bb63-436d-ad77-cd37969053708
1868469sodium bicarbonate 4.2 % (2.5 MEQ) per 5 ML InjectionSY0ab55004-bb63-436d-ad77-cd37969053708
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY0ab55004-bb63-436d-ad77-cd37969053708
1868469sodium bicarbonate 4.2 % (2.5 MEQ) in 5 ML InjectionPSN9545d58c-1c49-79b3-e053-2995a90a9d403
18684695 ML sodium bicarbonate 42 MG/ML InjectionSCD9545d58c-1c49-79b3-e053-2995a90a9d403
18684695 ML NaHCO3 42 MG/ML InjectionSY9545d58c-1c49-79b3-e053-2995a90a9d403
1868469sodium bicarbonate 4.2 % (2.5 MEQ) per 5 ML InjectionSY9545d58c-1c49-79b3-e053-2995a90a9d403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-083-03633230083035 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-083-056332300830525 VIAL, SINGLE-DOSE in 1 TRAY (63323-083-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-083-03) 2025-08-250000-00-00NoNoCurrent