FDA.reportPublic FDA data

SODIUM BICARBONATE

Product NDC
83854-001
Requested package NDC
83854-001-20
11-digit product format
838540001
Labeler code
83854
Product ID
83854-001_38887da2-9f53-8db2-e063-6294a90a7738
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Anthea Pharma Private Limited
Application
ANDA219701
Marketing category
ANDA
Marketing start
2025-06-26
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219701-001SODIUM BICARBONATESODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2025-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219701-001AP

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
2026-02-19 14:30 UTC2026-02A219701-001SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2025-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219701-001SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2025-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A219701-001SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAP2025-06-266a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219701-001SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAP2025-06-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219701-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219701-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219701-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219701-001AP1a50c72e98297…

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
0df8cf62-4b49-4ec4-aae4-c4a3e6d76549Available 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
83854-001-20SODIUM BICARBONATE20 in 1 CARTONINJECTION, SOLUTION203
83854-001-20SODIUM BICARBONATE50 mL in 1 VIALINJECTION, SOLUTION503
83854-001-25SODIUM BICARBONATE25 in 1 CARTONINJECTION, SOLUTION253
83854-001-25SODIUM BICARBONATE50 mL in 1 VIALINJECTION, SOLUTION503

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC.5401e4ff-aa7a-3e97-e063-6294a90a24f02026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219701
application number: ANDA219701
SODIUM BICARBONATESODIUM BICARBONATEGlenmark Pharmaceuticals Inc., USAf38d0dfc-9bcc-4224-a202-885c9ad0beae2025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219701
application number: ANDA219701
SODIUM BICARBONATESODIUM BICARBONATEAnthea Pharma Private Limited0df8cf62-4b49-4ec4-aae4-c4a3e6d765492025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219701
application number: ANDA219701
ndc (package): 83854-001-20
ndc (product): 83854-001
ndc11 (package): 83854000120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN0df8cf62-4b49-4ec4-aae4-c4a3e6d765493
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD0df8cf62-4b49-4ec4-aae4-c4a3e6d765493
186848650 ML NaHCO3 84 MG/ML InjectionSY0df8cf62-4b49-4ec4-aae4-c4a3e6d765493
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY0df8cf62-4b49-4ec4-aae4-c4a3e6d765493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83854-001-208385400012020 VIAL in 1 CARTON (83854-001-20) / 50 mL in 1 VIAL20 vial2025-06-26NoNoCurrent