FDA.reportPublic FDA data

INFANT 4.2% SODIUM BICARBONATE

Product NDC
51662-1310
Requested package NDC
51662-1310-1
11-digit product format
516621310
Labeler code
51662
Product ID
51662-1310_9f20c950-9021-3265-e053-2995a90a8239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INFANT 4.2% SODIUM BICARBONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-10-21
Marketing end
0000-00-00
Substance
SODIUM BICARBONATE
Active strength
42 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51662-131051662-1310-1DDiscontinued by firm2026-11-13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1310-12020-02-07C16284748780-19d75b9d0-a1a4-f424-e053-dadaa90a57ce4.2% SODIUM BICARBONATE INJ, USP 5mEq (0.5 mEq/mL) 10mL SYR
51662-1310-12020-01-31C16284748780-19d75b9d0-a1a4-f424-e053-dadaa90a57ce4.2% SODIUM BICARBONATE INJ, USP 5mEq (0.5 mEq/mL) 10mL SYR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1310-1INFANT 4.2% SODIUM BICARBONATE10 mL in 1 SYRINGEINJECTION, SOLUTION108
51662-1310-2INFANT 4.2% SODIUM BICARBONATE1 in 1 POUCHINJECTION, SOLUTION18
51662-1310-2INFANT 4.2% SODIUM BICARBONATE1 in 1 CARTONINJECTION, SOLUTION18
51662-1310-3INFANT 4.2% SODIUM BICARBONATE10 in 1 CASEINJECTION, SOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1310INFANT 4.2% SODIUM BICARBONATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]7Legacy NDC, 4 package rows20240517_78c25911-0042-664e-e053-2a91aa0a57a1.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
INFANT 4.2% SODIUM BICARBONATEINFANT 4.2% SODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst78c25911-0042-664e-e053-2a91aa0a57a12025-06-16Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1310-1
ndc (product): 51662-1310
ndc11 (package): 51662131001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868473sodium bicarbonate 4.2 % (5 MEQ) in 10 ML Prefilled SyringePSN78c25911-0042-664e-e053-2a91aa0a57a18
186847310 ML sodium bicarbonate 42 MG/ML Prefilled SyringeSCD78c25911-0042-664e-e053-2a91aa0a57a18
186847310 ML NaHCO3 42 MG/ML Prefilled SyringeSY78c25911-0042-664e-e053-2a91aa0a57a18
1868473sodium bicarbonate 4.2 % (5 MEQ) per 10 ML Prefilled SyringeSY78c25911-0042-664e-e053-2a91aa0a57a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1310-15166213100110 mL in 1 SYRINGE (51662-1310-1) 10 ml2018-10-210000-00-00NoNoCurrent