FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
51754-5002
11-digit product format
517545002
Labeler code
51754
Product ID
51754-5002_4da0ba66-756d-4b4d-8018-81ca16578ef1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
ANDA211091
Marketing category
ANDA
Marketing start
2020-09-01
Substance
SODIUM BICARBONATE
Active strength
75 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 BICARBONATE75 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MDF5V39QO
Rxcui807284, 1868486, 1923484, 2198792

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
51754-5002-5Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION503
51754-5002-5Sodium Bicarbonate20 in 1 CARTONINJECTION, SOLUTION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-5002SODIUM BICARBONATE INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]3Current NDC, Legacy NDC, 2 package rows20220826_e9698a4f-1a95-4f28-a945-e8009d1d6dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2198792sodium bicarbonate 4.2 % (5 MEQ) in 10 ML InjectionPSNe9698a4f-1a95-4f28-a945-e8009d1d6dd43
807284sodium bicarbonate 7.5 % (44.6 MEQ) in 50 ML InjectionPSNe9698a4f-1a95-4f28-a945-e8009d1d6dd43
1923484sodium bicarbonate 8.4 % (10 MEQ) in 10 mL InjectionPSNe9698a4f-1a95-4f28-a945-e8009d1d6dd43
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNe9698a4f-1a95-4f28-a945-e8009d1d6dd43
219879210 ML sodium bicarbonate 42 MG/ML InjectionSCDe9698a4f-1a95-4f28-a945-e8009d1d6dd43
192348410 ML sodium bicarbonate 84 MG/ML InjectionSCDe9698a4f-1a95-4f28-a945-e8009d1d6dd43
80728450 ML sodium bicarbonate 75 MG/ML InjectionSCDe9698a4f-1a95-4f28-a945-e8009d1d6dd43
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDe9698a4f-1a95-4f28-a945-e8009d1d6dd43
219879210 ML NaHCO3 42 MG/ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
192348410 ML NaHCO3 84 MG/ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
80728450 ML NaHCO3 75 MG/ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
186848650 ML NaHCO3 84 MG/ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
2198792sodium bicarbonate 4.2 % (5 MEQ) per 10 ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
807284sodium bicarbonate 7.5 % (44.6 MEQ) per 50 ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
1923484sodium bicarbonate 8.4 % (10 MEQ) per 10 ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43
1923484sodium bicarbonate 840 MG per 10 ML InjectionSYe9698a4f-1a95-4f28-a945-e8009d1d6dd43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-5002-55175450020520 VIAL in 1 CARTON (51754-5002-5) / 50 mL in 1 VIAL20 vial2020-09-010000-00-00NoNoCurrent