FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
81665-200
11-digit product format
816650200
Labeler code
81665
Product ID
81665-200_ada1be4a-11f4-4850-b98c-88e6ef02cd31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
OMNIVIUM PHARMACEUTICALS LLC.
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
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
81665-200-01Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION503
81665-200-05Sodium Bicarbonate20 in 1 CARTONINJECTION, SOLUTION203
81665-200-25Sodium Bicarbonate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81665-200SODIUM BICARBONATE INJECTION, SOLUTION [OMNIVIUM PHARMACEUTICALS LLC.]3Current NDC, 3 package rows20230815_aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc.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
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNaea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc3
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDaea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc3
186848650 ML NaHCO3 84 MG/ML InjectionSYaea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc3
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYaea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81665-200-018166502000150 mL in 1 VIAL50 mlHistorical
81665-200-058166502000520 VIAL in 1 CARTON (81665-200-05) / 50 mL in 1 VIAL (81665-200-01) 20 vial2023-06-16NoNoHistorical
81665-200-258166502002525 VIAL in 1 CARTON (81665-200-25) / 50 mL in 1 VIAL (81665-200-01) 25 vial2023-06-16NoNoHistorical