SODIUM BICARBONATE

Product NDC
80830-2305
11-digit product format
808302305
Labeler code
80830
Product ID
80830-2305_cc28f253-e8e4-40b1-aaf8-1218fc83674c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium bicarbonate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals Private Limited
Application
ANDA217523
Marketing category
ANDA
Marketing start
2026-01-13
Substance
SODIUM BICARBONATE
Active strength
84 mg/mL
Pharmacologic classes
Alkalinizing Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM BICARBONATE
Listing expiration
2027-12-31

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
80830-2305-1SODIUM BICARBONATE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION503
80830-2305-2SODIUM BICARBONATE25 in 1 CARTONINJECTION, SOLUTION253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNba92f45a-0187-4709-aa70-462b8dae09e93
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDba92f45a-0187-4709-aa70-462b8dae09e93
186848650 ML NaHCO3 84 MG/ML InjectionSYba92f45a-0187-4709-aa70-462b8dae09e93
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYba92f45a-0187-4709-aa70-462b8dae09e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80830-2305-18083023050150 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical
80830-2305-28083023050225 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2) / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1) 2026-01-13NoNoHistorical