FDA.reportPublic FDA data

CAFFEINE CITRATE

Product NDC
72485-104
11-digit product format
724850104
Labeler code
72485
Product ID
72485-104_2cd4c6d2-3786-4e00-abd0-0d62d2c18e0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Caffeine Citrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA207400
Marketing category
ANDA
Marketing start
2020-01-01
Substance
CAFFEINE CITRATE
Active strength
60 mg/3mL
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 CITRATE60 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU26EO4675Q
Rxcui849931

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
72485-104-01CAFFEINE CITRATE3 mL in 1 VIAL, GLASSINJECTION35
72485-104-01CAFFEINE CITRATE1 in 1 CARTONINJECTION15
72485-104-10CAFFEINE CITRATE1 in 1 CARTONINJECTION15
72485-104-10CAFFEINE CITRATE10 in 1 BOXINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-104-01ML - Milliliter72485-1048e834918-bda7-4324-aea2-1a7c0e145ac212020-02-13
72485-104-10ML - Milliliter72485-104d74ad1ac-bd1a-4b7c-ab13-f16dff99323612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-104CAFFEINE CITRATE (CAFFEINE CITRATE) INJECTION [ARMAS PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20230802_c1129235-f7f6-43eb-8d6e-786c14c16f2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849931caffeine citrate 60 MG in 3 ML InjectionPSNc1129235-f7f6-43eb-8d6e-786c14c16f2f5
8499313 ML caffeine citrate 20 MG/ML InjectionSCDc1129235-f7f6-43eb-8d6e-786c14c16f2f5
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSYc1129235-f7f6-43eb-8d6e-786c14c16f2f5
849931caffeine citrate 60 MG per 3 ML InjectionSYc1129235-f7f6-43eb-8d6e-786c14c16f2f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-104-01724850104011 VIAL, GLASS in 1 CARTON (72485-104-01) / 3 mL in 1 VIAL, GLASS2020-01-010000-00-00NoNoCurrent
72485-104-107248501041010 CARTON in 1 BOX (72485-104-10) / 1 VIAL, GLASS in 1 CARTON / 3 mL in 1 VIAL, GLASS10 carton2020-03-010000-00-00NoNoCurrent