Caffeine and Sodium Benzoate

Product NDC
0517-2502
11-digit product format
005172502
Labeler code
0517
Product ID
0517-2502_53245845-b446-46f8-bbe8-3323c58e10e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Caffeine and Sodium Benzoate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
American Regent, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1993-02-01
Substance
CAFFEINE
Active strength
125 mg/mL
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Caffeine and Sodium Benzoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE125 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3G6A5W338EInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2c6b352-f837-4903-8e4c-fb0a2b20bb60Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-2502-01Caffeine and Sodium Benzoate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION27
0517-2502-10Caffeine and Sodium Benzoate10 in 1 BOXINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-2502-01ML - Milliliter0517-2502d7f8e535-ca10-4ba1-a0b6-b855c1d9293612019-04-11
0517-2502-10ML - Milliliter0517-2502d29437c4-d880-4d96-8542-9b17a6fc2fc012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-2502CAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]7Current NDC, Legacy NDC, 2 package rows20221228_b2c6b352-f837-4903-8e4c-fb0a2b20bb60.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
Caffeine and Sodium BenzoateCAFFEINE AND SODIUM BENZOATEAmerican Regent, Inc.b2c6b352-f837-4903-8e4c-fb0a2b20bb602019-12-06Exact identifier
ndc (product): 0517-2502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-2502-01005172502012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0517-2502-100051725021010 VIAL, SINGLE-DOSE in 1 BOX (0517-2502-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-2502-01) 1993-02-010000-00-00NoNoCurrent