Home NDC 51754-0501 caffeine citrate
Product NDC 51754-0501
11-digit product format 517540501
Labeler code 51754
Product ID 51754-0501_6717d816-ee3c-4633-ba00-98e539734243
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CAFFEINE CITRATE
Dosage form SOLUTION
Route ORAL
Labeler Exela Pharma Sciences, LLC
Application ANDA077304
Marketing category ANDA
Marketing start 2006-09-21
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 A077304-001 CAFFEINE CITRATE CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077304-001 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 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2006-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077304-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA RS 2006-09-21 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 51754-0501-2 caffeine citrate 5 in 1 CARTON SOLUTION 5 3 51754-0501-2 caffeine citrate 3 mL in 1 VIAL SOLUTION 3 3 51754-0501-3 caffeine citrate 3 mL in 1 VIAL SOLUTION 3 3 51754-0501-3 caffeine citrate 10 in 1 CARTON SOLUTION 10 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-0501 CAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC] 3 Current NDC, Legacy NDC, 4 package rows 20200103_5d05ebf4-fd27-3bd1-5634-b41e33abc41f.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 51754-0501-2 51754050102 5 VIAL in 1 CARTON (51754-0501-2) / 3 mL in 1 VIAL 5 vial 2019-08-31 0000-00-00 No No Current 51754-0501-3 51754050103 10 VIAL in 1 CARTON (51754-0501-3) / 3 mL in 1 VIAL 10 vial 2015-03-30 0000-00-00 No No Current