Home NDC 51754-0503 caffeine citrate
Product NDC 51754-0503
11-digit product format 517540503
Labeler code 51754
Product ID 51754-0503_74eacede-e465-482b-979f-773b4d531764
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
Marketing end 0000-00-00
Substance CAFFEINE CITRATE
Active strength 20 mg/mL
Pharmacologic classes Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51754-0503-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51754-0503-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51754-0503-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51754-0503-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51754-0503-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51754-0503-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51754-0503-3 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51754-0503-3 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51754-0503-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 51754-0503-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 51754-0503-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-0503 CAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC] 2 Legacy NDC 20210318_bd6ac18d-c65c-42bc-a3ca-7a428c13aae7.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51754-0503-3 51754050303 10 VIAL, SINGLE-DOSE in 1 CONTAINER (51754-0503-3) > 3 mL in 1 VIAL, SINGLE-DOSE 2006-09-21 0000-00-00 No No Current