FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
72572-740
11-digit product format
725720740
Labeler code
72572
Product ID
72572-740_8fcbd37e-e4d5-4137-9abf-c398fbb5cbf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Civica
Application
ANDA211091
Marketing category
ANDA
Marketing start
2019-08-01
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
72572-740-25Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION503
72572-740-25Sodium Bicarbonate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-740-20ML - Milliliter72572-740de9e6ea1-44c0-4ede-ba0f-913e3b774e5e12020-03-10
72572-740-25ML - Milliliter72572-74014ae7843-8fe6-4e55-b46b-a294931094da12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-740SODIUM BICARBONATE INJECTION, SOLUTION [CIVICA]2Current NDC, Legacy NDC, 2 package rows20240110_a10fdfbc-94a0-49ab-b26c-de1df042bc89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNa10fdfbc-94a0-49ab-b26c-de1df042bc893
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDa10fdfbc-94a0-49ab-b26c-de1df042bc893
186848650 ML NaHCO3 84 MG/ML InjectionSYa10fdfbc-94a0-49ab-b26c-de1df042bc893
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYa10fdfbc-94a0-49ab-b26c-de1df042bc893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-740-207257207402020 VIAL in 1 CARTON (72572-740-20) > 50 mL in 1 VIAL20 vial2020-03-010000-00-00NoNoCurrent
72572-740-257257207402525 VIAL in 1 CARTON (72572-740-25) / 50 mL in 1 VIAL25 vial2024-02-01NoNoHistorical