Caffeine Citrate

Product NDC
47335-290
11-digit product format
473350290
Labeler code
47335
Product ID
47335-290_dd824465-e6da-459b-9f40-2ddb0fd98cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Caffeine Citrate
Dosage form
SOLUTION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090357
Marketing category
ANDA
Marketing start
2021-03-01
Substance
CAFFEINE CITRATE
Active strength
20 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 Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE CITRATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU26EO4675Q
Rxcui849928, 849931

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
47335-290-40Caffeine Citrate3 mL in 1 VIAL, SINGLE-DOSESOLUTION38
47335-290-44Caffeine Citrate10 in 1 CONTAINERSOLUTION108
47335-290-26Caffeine Citrate3 mL in 1 VIAL, SINGLE-DOSESOLUTION34
47335-290-27Caffeine Citrate10 in 1 CONTAINERSOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-290-26ML - Milliliter47335-290dddb98c9-6e38-4af5-bf30-ea444084bf8512014-10-03
47335-290-27ML - Milliliter47335-2900b17f28b-2be6-49a4-ab7d-7774eb62679012014-10-03
47335-290-40ML - Milliliter47335-2905077a984-33e9-408d-9907-50d8a6b33d4e12021-07-15
47335-290-44ML - Milliliter47335-290a1766a18-4ddc-48ed-9e12-c9f8fec520ba12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-290CAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 2 package rows20210301_cc632825-e0a4-4524-8d7d-ce926efab3d6.zip
47335-290CAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 2 package rows20190302_d06d3810-9923-4199-be5e-ee5ee086b0a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849931caffeine citrate 60 MG in 3 ML InjectionPSNcc632825-e0a4-4524-8d7d-ce926efab3d68
849928caffeine citrate 60 MG in 3 mL Oral SolutionPSNcc632825-e0a4-4524-8d7d-ce926efab3d68
8499313 ML caffeine citrate 20 MG/ML InjectionSCDcc632825-e0a4-4524-8d7d-ce926efab3d68
849928caffeine citrate 20 MG/ML Oral SolutionSCDcc632825-e0a4-4524-8d7d-ce926efab3d68
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSYcc632825-e0a4-4524-8d7d-ce926efab3d68
849931caffeine citrate 60 MG per 3 ML InjectionSYcc632825-e0a4-4524-8d7d-ce926efab3d68
849928caffeine citrate 60 MG per 3 ML Oral SolutionSYcc632825-e0a4-4524-8d7d-ce926efab3d68
849931caffeine citrate 60 MG in 3 ML InjectionPSNd06d3810-9923-4199-be5e-ee5ee086b0a44
849928caffeine citrate 60 MG in 3 mL Oral SolutionPSNd06d3810-9923-4199-be5e-ee5ee086b0a44
8499313 ML caffeine citrate 20 MG/ML InjectionSCDd06d3810-9923-4199-be5e-ee5ee086b0a44
849928caffeine citrate 20 MG/ML Oral SolutionSCDd06d3810-9923-4199-be5e-ee5ee086b0a44
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSYd06d3810-9923-4199-be5e-ee5ee086b0a44
849931caffeine citrate 60 MG per 3 ML InjectionSYd06d3810-9923-4199-be5e-ee5ee086b0a44
849928caffeine citrate 60 MG per 3 ML Oral SolutionSYd06d3810-9923-4199-be5e-ee5ee086b0a44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-290-26473350290263 mL in 1 VIAL, SINGLE-DOSE3 mlHistorical
47335-290-274733502902710 in 1 CONTAINERHistorical
47335-290-40473350290403 mL in 1 VIAL, SINGLE-DOSE3 mlHistorical
47335-290-444733502904410 VIAL, SINGLE-DOSE in 1 CONTAINER (47335-290-44) / 3 mL in 1 VIAL, SINGLE-DOSE (47335-290-40) 2021-03-010000-00-00NoNoCurrent