Caffeine Citrate

Product NDC
55150-187
11-digit product format
551500187
Labeler code
55150
Product ID
55150-187_436fad85-f84e-414f-aada-124cae0166d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Caffeine Citrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA205013
Marketing category
ANDA
Marketing start
2015-09-22
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205013-001CAFFEINE CITRATECAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2015-09-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2015-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2015-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2015-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUS2015-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205013-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / INTRAVENOUSAP2015-09-22e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205013-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205013-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205013-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205013-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205013-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205013-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205013-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205013-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205013-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205013-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205013-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205013-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205013-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205013-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205013-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205013-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205013-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205013-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A205013-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205013-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205013-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205013-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A205013-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205013-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205013-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205013-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205013-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205013-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205013-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205013-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205013-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205013-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205013-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205013-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205013-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205013-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205013-001AP1cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U26EO4675QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849931Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ef448ca-5549-4272-a6b4-5c4f57653c4cAvailable 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
55150-187-03Caffeine Citrate3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION36
55150-187-03Caffeine Citrate1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-187-03ML - Milliliter55150-18741a49ab2-8d72-43d9-a5bd-da5b360acc9d12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINE CITRATEACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCAFFEINE CITRATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCAFFEINE CITRATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-187CAFFEINE CITRATE INJECTION, SOLUTION [EUGIA US LLC]6Current NDC, Legacy NDC, 2 package rows20250426_8ef448ca-5549-4272-a6b4-5c4f57653c4c.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 CitrateCAFFEINE CITRATEEugia US LLC8ef448ca-5549-4272-a6b4-5c4f57653c4c2025-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205013
application number: ANDA205013
ndc (product): 55150-187

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849931caffeine citrate 60 MG in 3 ML InjectionPSN8ef448ca-5549-4272-a6b4-5c4f57653c4c6
8499313 ML caffeine citrate 20 MG/ML InjectionSCD8ef448ca-5549-4272-a6b4-5c4f57653c4c6
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSY8ef448ca-5549-4272-a6b4-5c4f57653c4c6
849931caffeine citrate 60 MG per 3 ML InjectionSY8ef448ca-5549-4272-a6b4-5c4f57653c4c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-187-03551500187031 VIAL, SINGLE-DOSE in 1 CARTON (55150-187-03) / 3 mL in 1 VIAL, SINGLE-DOSE2015-09-220000-00-00NoNoCurrent