FDA.reportPublic FDA data

SODIUM BICARBONATE

Product NDC
70095-050
11-digit product format
700950050
Labeler code
70095
Product ID
70095-050_5ae65432-04a1-4b6b-8536-2535064fc782
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries Limited
Application
ANDA217594
Marketing category
ANDA
Marketing start
2024-03-15
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
70095-050-01SODIUM BICARBONATE50 mL in 1 VIALINJECTION, SOLUTION501
70095-050-03SODIUM BICARBONATE25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70095-050-01ML - Milliliter70095-0500b705a1e-c224-48e2-beef-d505ae63a63712024-04-05
70095-050-03ML - Milliliter70095-05028a50545-f832-4857-b7a0-1e9af7eb52e312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70095-050SODIUM BICARBONATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]1Current NDC, 2 package rows20240316_5ae65432-04a1-4b6b-8536-2535064fc782.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN3867f743-c2cf-a646-e063-6394a90a82e14
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD3867f743-c2cf-a646-e063-6394a90a82e14
186848650 ML NaHCO3 84 MG/ML InjectionSY3867f743-c2cf-a646-e063-6394a90a82e14
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY3867f743-c2cf-a646-e063-6394a90a82e14
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN4f97d398-2118-0874-e063-6394a90a4ad11
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN5ae65432-04a1-4b6b-8536-2535064fc7821
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD4f97d398-2118-0874-e063-6394a90a4ad11
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD5ae65432-04a1-4b6b-8536-2535064fc7821
186848650 ML NaHCO3 84 MG/ML InjectionSY4f97d398-2118-0874-e063-6394a90a4ad11
186848650 ML NaHCO3 84 MG/ML InjectionSY5ae65432-04a1-4b6b-8536-2535064fc7821
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY4f97d398-2118-0874-e063-6394a90a4ad11
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY5ae65432-04a1-4b6b-8536-2535064fc7821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70095-050-017009500500150 mL in 1 VIAL50 mlHistorical
70095-050-037009500500325 VIAL in 1 CARTON (70095-050-03) / 50 mL in 1 VIAL (70095-050-01) 25 vial2024-03-15NoNoCurrent