FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
72572-740
Requested package NDC
72572-740-25
11-digit product format
725720740
Labeler code
72572
Product ID
72572-740_8fcbd37e-e4d5-4137-9abf-c398fbb5cbf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Civica
Application
ANDA211091
Marketing category
ANDA
Marketing start
2019-08-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211091-001SODIUM BICARBONATESODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20
A211091-002SODIUM BICARBONATESODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20
A211091-003SODIUM BICARBONATESODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20
A211091-004SODIUM BICARBONATESODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211091-001AP
A211091-002AP
A211091-003AP
A211091-004AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211091-001SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20a50c72e98297…
2026-08-01 22:54:322026-06A211091-002SODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20a50c72e98297…
2026-08-01 22:54:322026-06A211091-003SODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20a50c72e98297…
2026-08-01 22:54:322026-06A211091-004SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211091-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A211091-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A211091-003AP1a50c72e98297…
2026-08-01 22:54:322026-06A211091-004AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLC2f05947f-a489-4298-a871-90db75b2a6c52026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211091
application number: ANDA211091
Sodium BicarbonateSODIUM BICARBONATECivicaa10fdfbc-94a0-49ab-b26c-de1df042bc892025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211091
application number: ANDA211091
ndc (package): 72572-740-25
ndc (product): 72572-740
ndc11 (package): 72572074025
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutionsd89406d3-4356-4a8c-acc1-89efe1d270102023-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211091
application number: ANDA211091
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLC09cf38c2-0b44-eca1-e063-6294a90a72d82023-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211091
application number: ANDA211091
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCe9698a4f-1a95-4f28-a945-e8009d1d6dd42017-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211091
application number: ANDA211091

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1868486Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a10fdfbc-94a0-49ab-b26c-de1df042bc89Available on FDA.report

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
72572-740-25Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION503
72572-740-25Sodium Bicarbonate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-740-20ML - Milliliter72572-740de9e6ea1-44c0-4ede-ba0f-913e3b774e5e12020-03-10
72572-740-25ML - Milliliter72572-74014ae7843-8fe6-4e55-b46b-a294931094da12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-740SODIUM BICARBONATE INJECTION, SOLUTION [CIVICA]2Current NDC, Legacy NDC, 2 package rows20240110_a10fdfbc-94a0-49ab-b26c-de1df042bc89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNa10fdfbc-94a0-49ab-b26c-de1df042bc893
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDa10fdfbc-94a0-49ab-b26c-de1df042bc893
186848650 ML NaHCO3 84 MG/ML InjectionSYa10fdfbc-94a0-49ab-b26c-de1df042bc893
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYa10fdfbc-94a0-49ab-b26c-de1df042bc893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72572-740-257257207402525 VIAL in 1 CARTON (72572-740-25) / 50 mL in 1 VIAL25 vial2024-02-01NoNoCurrent