Sodium Bicarbonate

Product NDC
82449-000
11-digit product format
824490000
Labeler code
82449
Product ID
82449-000_12d2a9ac-f0d0-e207-e063-6394a90a8f56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Steriscience Specialties Private Limited
Application
ANDA217594
Marketing category
ANDA
Marketing start
2024-03-08
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
82449-000-05Sodium Bicarbonate20 in 1 CARTONINJECTION, SOLUTION203
82449-000-05Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82449-000SODIUM BICARBONATE INJECTION, SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]3Current NDC, 2 package rows20240308_eb2996b4-c04c-4678-b8a9-5cbbe509bb70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNeb2996b4-c04c-4678-b8a9-5cbbe509bb703
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDeb2996b4-c04c-4678-b8a9-5cbbe509bb703
186848650 ML NaHCO3 84 MG/ML InjectionSYeb2996b4-c04c-4678-b8a9-5cbbe509bb703
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYeb2996b4-c04c-4678-b8a9-5cbbe509bb703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82449-000-058244900000520 VIAL in 1 CARTON (82449-000-05) / 50 mL in 1 VIAL20 vial2024-03-08NoNoHistorical