FDA.reportPublic FDA data

SODIUM BICARBONATE

Product NDC
0409-6625
11-digit product format
004096625
Labeler code
0409
Product ID
0409-6625_c39c0ef6-4140-4c6c-91c4-e43d67872b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA202432
Marketing category
ANDA
Marketing start
2021-03-01
Substance
SODIUM BICARBONATE
Active strength
84 mg/mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM BICARBONATE
Listing expiration
2027-12-31

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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6625-14SODIUM BICARBONATE25 in 1 TRAYINJECTION, SOLUTION257
0409-6625-22SODIUM BICARBONATE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION507
0409-6625-30Sodium Bicarbonate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION506
0409-6625-35Sodium Bicarbonate25 in 1 TRAYINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6625-02ML - Milliliter0409-662543b21a0f-fb38-4f31-a1a2-977bf3f19d3012013-02-13
0409-6625-14ML - Milliliter0409-6625bfd7dd3e-7a42-415b-b369-3add7183e68812021-04-08
0409-6625-22ML - Milliliter0409-6625f04cc21b-a21c-42b3-94a4-e0637e1a705f12021-04-08
0409-6625-25ML - Milliliter0409-66254e5f9752-f87f-4049-b563-97c220e3b7de12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOSODIUM BICARBONATE INJECTION, SOLUTION [US MEDSOURCE, LLC]1
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20SODIUM BICARBONATE INJECTION, SOLUTION [US MEDSOURCE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM BICARBONATE INJECTION, SOLUTION [US MEDSOURCE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6625SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.]5Current NDC, Legacy NDC, 2 package rows20250504_084f5572-8c1f-4802-b179-ca0cc838fc68.zip
0409-6625SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.]4Current NDC, Legacy NDC, 2 package rows20250523_8664c7ce-707b-4c6c-9ce4-7160b5f877f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN619cb558-84e5-43ea-91e9-28c764f9f9c016
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD619cb558-84e5-43ea-91e9-28c764f9f9c016
186848650 ML NaHCO3 84 MG/ML InjectionSY619cb558-84e5-43ea-91e9-28c764f9f9c016
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY619cb558-84e5-43ea-91e9-28c764f9f9c016
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN74d8bb7a-9e7a-105f-e053-2a91aa0aec927
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN084f5572-8c1f-4802-b179-ca0cc838fc687
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD084f5572-8c1f-4802-b179-ca0cc838fc687
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD74d8bb7a-9e7a-105f-e053-2a91aa0aec927
186848650 ML NaHCO3 84 MG/ML InjectionSY74d8bb7a-9e7a-105f-e053-2a91aa0aec927
186848650 ML NaHCO3 84 MG/ML InjectionSY084f5572-8c1f-4802-b179-ca0cc838fc687
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY74d8bb7a-9e7a-105f-e053-2a91aa0aec927
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY084f5572-8c1f-4802-b179-ca0cc838fc687
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN8664c7ce-707b-4c6c-9ce4-7160b5f877f86
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD8664c7ce-707b-4c6c-9ce4-7160b5f877f86
186848650 ML NaHCO3 84 MG/ML InjectionSY8664c7ce-707b-4c6c-9ce4-7160b5f877f86
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY8664c7ce-707b-4c6c-9ce4-7160b5f877f86
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSN2a262fe3-8a64-4dc5-954a-1d51fb72747b1
1868486sodium bicarbonate 8.4 % (50 MEQ) in 50 ML InjectionPSNbfc9c321-665c-ca97-e053-2995a90a79541
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCD2a262fe3-8a64-4dc5-954a-1d51fb72747b1
186848650 ML sodium bicarbonate 84 MG/ML InjectionSCDbfc9c321-665c-ca97-e053-2995a90a79541
186848650 ML NaHCO3 84 MG/ML InjectionSY2a262fe3-8a64-4dc5-954a-1d51fb72747b1
186848650 ML NaHCO3 84 MG/ML InjectionSYbfc9c321-665c-ca97-e053-2995a90a79541
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSY2a262fe3-8a64-4dc5-954a-1d51fb72747b1
1868486sodium bicarbonate 8.4 % (50 MEQ) per 50 ML InjectionSYbfc9c321-665c-ca97-e053-2995a90a79541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6625-020040966250225 VIAL in 1 TRAY (0409-6625-02) > 50 mL in 1 VIAL25 vial2005-03-310000-00-00NoNoCurrent
0409-6625-140040966251425 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-14) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-22) 2021-03-010000-00-00NoNoCurrent
0409-6625-220040966252250 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical
0409-6625-250040966252525 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-25) > 50 mL in 1 VIAL, SINGLE-DOSE2014-03-132022-01-01NoNoCurrent
0409-6625-300040966253050 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical
0409-6625-350040966253525 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-35) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-30) 2020-10-150000-00-00NoNoCurrent