Home NDC 47335-289-40 Caffeine Citrate
Product NDC 47335-289
Requested package NDC 47335-289-40
11-digit product format 473350289
Labeler code 47335
Product ID 47335-289_f32e4ba0-3e6d-41b3-95f3-67b040cd4529
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Caffeine Citrate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090077
Marketing category ANDA
Marketing start 2014-06-05
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A090077-001 CAFFEINE CITRATE CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30
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 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2009-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2009-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2009-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP 2009-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090077-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS 2009-09-30 e64feba35796…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849928 Internal RxNorm lookup 849931 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 47335-289-40 Caffeine Citrate 3 mL in 1 VIAL, SINGLE-DOSE INJECTION 3 8 47335-289-40 Caffeine Citrate 1 in 1 CARTON INJECTION 1 8 47335-289-26 Caffeine Citrate 3 mL in 1 VIAL, SINGLE-DOSE INJECTION 3 4 47335-289-27 Caffeine Citrate 1 in 1 CARTON INJECTION 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-289 CAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20210301_cc632825-e0a4-4524-8d7d-ce926efab3d6.zip 47335-289 CAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20190302_d06d3810-9923-4199-be5e-ee5ee086b0a4.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 47335-289-40 47335028940 1 VIAL, SINGLE-DOSE in 1 CARTON (47335-289-40) > 3 mL in 1 VIAL, SINGLE-DOSE 2009-10-01 0000-00-00 No No Current