Home NDC 42571-346 Caffeine Citrate
Product NDC 42571-346
11-digit product format 425710346
Labeler code 42571
Product ID 42571-346_3afcab4c-73cc-7575-e063-6394a90a782e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Caffeine Citrate
Dosage form SOLUTION
Route ORAL
Labeler Micro Labs Limited
Application ANDA213202
Marketing category ANDA
Marketing start 2020-02-01
Substance CAFFEINE CITRATE
Active strength 60 mg/3mL
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 A213202-001 CAFFEINE CITRATE CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213202-001 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.
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 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213202-001 CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL AA 2019-12-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Caffeine Citrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE CITRATE 60 mg/3mL
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 42571-346-69 Caffeine Citrate 10 in 1 BOX SOLUTION 10 4 42571-346-69 Caffeine Citrate 3 mL in 1 VIAL SOLUTION 3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-346 CAFFEINE CITRATE (CAFFEINE CITRATE) SOLUTION [MICRO LABS LIMITED] 3 Current NDC, Legacy NDC, 2 package rows 20241016_db4477a3-b291-4b77-9eca-b7ba8f66b2be.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 Units Marketing start Marketing end Sample Exclude flag Status 42571-346-69 42571034669 10 VIAL in 1 BOX (42571-346-69) / 3 mL in 1 VIAL 10 vial 2020-02-01 0000-00-00 No No Current 42571-346-96 42571034696 5 VIAL in 1 BOX (42571-346-96) / 3 mL in 1 VIAL 5 vial 2026-04-23 0 Current