Sodium Bicarbonate

Product NDC
50090-6813
11-digit product format
500906813
Labeler code
50090
Product ID
50090-6813_132e1b7b-c63c-43d3-ac31-8ca034f1210f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
A-S Medication Solutions
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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211091-001SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211091-002SODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211091-003SODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211091-004SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-001SODIUM BICARBONATE5MEQ/10ML (0.5MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-002SODIUM BICARBONATE44.6MEQ/50ML (0.9MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-003SODIUM BICARBONATE10MEQ/10ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-004SODIUM BICARBONATE50MEQ/50ML (1MEQ/ML)SOLUTION / INTRAVENOUSAPRS2019-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211091-003SODIUM BICARBONATE1MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211091-001SODIUM BICARBONATE0.5MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211091-002SODIUM BICARBONATE0.9MEQ/MLINJECTABLE / INJECTIONAPRS2019-06-201e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211091-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211091-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211091-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211091-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211091-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211091-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211091-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211091-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211091-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211091-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211091-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211091-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211091-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211091-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211091-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211091-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211091-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211091-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211091-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211091-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211091-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211091-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211091-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211091-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211091-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211091-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211091-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211091-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211091-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211091-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211091-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211091-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211091-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211091-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211091-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211091-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211091-002AP11e350fbaab3a…

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
d89406d3-4356-4a8c-acc1-89efe1d27010Available 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
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
50090-6813-0Sodium Bicarbonate1 in 1 CARTONINJECTION, SOLUTION12
50090-6813-0Sodium Bicarbonate50 mL in 1 VIALINJECTION, SOLUTION502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6813-0ML - Milliliter50090-6813ed0a44d5-fde3-4f17-80b9-f42f5733d48612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6813SODIUM BICARBONATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20231115_d89406d3-4356-4a8c-acc1-89efe1d27010.zip

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 · 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
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutionsd89406d3-4356-4a8c-acc1-89efe1d270102023-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211091
application number: ANDA211091
ndc (product): 50090-6813
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNd89406d3-4356-4a8c-acc1-89efe1d270102
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDd89406d3-4356-4a8c-acc1-89efe1d270102
186848650 ML NaHCO3 84 MG/ML InjectionSYd89406d3-4356-4a8c-acc1-89efe1d270102
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYd89406d3-4356-4a8c-acc1-89efe1d270102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6813-0500906813001 VIAL in 1 CARTON (50090-6813-0) / 50 mL in 1 VIAL1 vial2023-11-08NoNoCurrent