SODIUM BICARBONATE

Product NDC
68462-951
11-digit product format
684620951
Labeler code
68462
Product ID
68462-951_f38d0dfc-9bcc-4224-a202-885c9ad0beae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA219701
Marketing category
ANDA
Marketing start
2025-08-07
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
68462-951-50SODIUM BICARBONATE50 mL in 1 VIALINJECTION, SOLUTION501
68462-951-65SODIUM BICARBONATE25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-951-50ML - Milliliter68462-951986a24c6-202c-4130-a95e-303a3c0fe9f812025-12-16
68462-951-65ML - Milliliter68462-95194ce7e5d-760a-4c77-b20b-6057843b9ef812025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNf38d0dfc-9bcc-4224-a202-885c9ad0beae1
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDf38d0dfc-9bcc-4224-a202-885c9ad0beae1
186848650 ML NaHCO3 84 MG/ML InjectionSYf38d0dfc-9bcc-4224-a202-885c9ad0beae1
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYf38d0dfc-9bcc-4224-a202-885c9ad0beae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-951-506846209515050 mL in 1 VIAL50 mlHistorical
68462-951-656846209516525 VIAL in 1 CARTON (68462-951-65) / 50 mL in 1 VIAL (68462-951-50) 25 vial2025-08-07NoNoCurrent