FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
64980-528
11-digit product format
649800528
Labeler code
64980
Product ID
64980-528_2dcd3695-0d50-4ff4-9c9c-171b351156f4
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M001.30
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-20
Substance
SODIUM BICARBONATE
Active strength
650 mg/1
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 BICARBONATE650 mg/1

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
198861Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3eAvailable 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
64980-528-10Sodium Bicarbonate1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-528-10EA - Each64980-528567125ae-6e9b-460b-8477-9b5fde25a97412021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-528SODIUM BICARBONATE TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 1 package rows20241103_f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATERising Pharma Holdings, Inc.f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e2024-11-01Boxed warning, WarningsExact identifier
ndc (product): 64980-528

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN4493d7c5-f2c3-416e-a5c1-35398fc7f61d104
198861sodium bicarbonate 650 MG Oral TabletSCD4493d7c5-f2c3-416e-a5c1-35398fc7f61d104
198861NaHCO3 650 MG Oral TabletSY4493d7c5-f2c3-416e-a5c1-35398fc7f61d104
198861sodium bicarbonate 10 Grains Oral TabletSY4493d7c5-f2c3-416e-a5c1-35398fc7f61d104
198861sodium bicarbonate 648 MG Oral TabletSY4493d7c5-f2c3-416e-a5c1-35398fc7f61d104
198861sodium bicarbonate 650 MG Oral TabletPSNf5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e3
198861sodium bicarbonate 650 MG Oral TabletSCDf5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e3
198861NaHCO3 650 MG Oral TabletSYf5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e3
198861sodium bicarbonate 10 Grains Oral TabletSYf5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e3
198861sodium bicarbonate 648 MG Oral TabletSYf5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-528-10649800528101000 TABLET in 1 BOTTLE (64980-528-10) 1000 tablet2020-07-200000-00-00NoNoCurrent