Home NDC 63323-406 Caffeine Citrate
Product NDC 63323-406
11-digit product format 633230406
Labeler code 63323
Product ID 63323-406_8d47943c-b6f3-4742-90fe-4667e19c8605
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CAFFEINE CITRATE
Dosage form SOLUTION
Route ORAL
Labeler Fresenius Kabi USA, LLC
Application ANDA078002
Marketing category ANDA
Marketing start 2009-11-19
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078002-001 CAFFEINE CITRATE CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078002-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078002-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2008-01-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Caffeine Citrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE CITRATE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U26EO4675Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849928 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-406-01 Caffeine Citrate 3 mL in 1 VIAL SOLUTION 3 5 63323-406-03 Caffeine Citrate 5 in 1 CARTON SOLUTION 5 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-406 CAFFEINE CITRATE SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20190430_b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-406-01 63323040601 3 mL in 1 VIAL 3 ml Historical 63323-406-03 63323040603 5 VIAL in 1 CARTON (63323-406-03) / 3 mL in 1 VIAL (63323-406-01) 5 vial 2009-11-19 0000-00-00 No No Current