FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
72162-2314
11-digit product format
721622314
Labeler code
72162
Product ID
72162-2314_f5039a39-178c-4a1c-9dcc-2d93e57378d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Bryant Ranch Prepack
Application
ANDA216364
Marketing category
ANDA
Marketing start
2023-06-16
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2314-2Sodium Bicarbonate20 in 1 CARTONINJECTION, SOLUTION20101
72162-2314-4Sodium Bicarbonate25 in 1 CARTONINJECTION, SOLUTION25101
72162-2314-7Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION50101
72162-2314-8Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION50101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2314-2ML - Milliliter72162-2314fdc924e4-41a9-4e80-a913-40f86048574d12024-07-12
72162-2314-4ML - Milliliter72162-23141647e95f-1532-4ebd-acdf-ca9ca6386c2e12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2314SODIUM BICARBONATE INJECTION, SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20240524_ccf8e08c-2efb-4a92-a4c2-042dba2eacfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNccf8e08c-2efb-4a92-a4c2-042dba2eacfa101
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDccf8e08c-2efb-4a92-a4c2-042dba2eacfa101
186848650 ML NaHCO3 84 MG/ML InjectionSYccf8e08c-2efb-4a92-a4c2-042dba2eacfa101
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYccf8e08c-2efb-4a92-a4c2-042dba2eacfa101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2314-27216223140220 VIAL in 1 CARTON (72162-2314-2) / 50 mL in 1 VIAL (72162-2314-7) 20 vial2024-05-22NoNoCurrent
72162-2314-47216223140425 VIAL in 1 CARTON (72162-2314-4) / 50 mL in 1 VIAL (72162-2314-8) 25 vial2024-05-22NoNoCurrent
72162-2314-77216223140750 mL in 1 VIAL50 mlHistorical
72162-2314-87216223140850 mL in 1 VIAL50 mlHistorical