Home NDC 0641-6164 CAFCIT
Product NDC 0641-6164
11-digit product format 006416164
Labeler code 0641
Product ID 0641-6164_ebbc55dd-77a6-4382-9c59-b470a280bbd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name caffeine citrate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA020793
Marketing category NDA
Marketing start 2008-11-04
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 2021-12-31
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 · 26 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 0641-6164-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0641-6164-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0641-6164-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0641-6164-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0641-6164-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0641-6164-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0641-6164-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0641-6164-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0641-6164-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0641-6164-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0641-6164-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0641-6164-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product E Excluded after deficient or non-compliant submission was not corrected 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0641-6164-10 E Excluded after deficient or non-compliant submission was not corrected 8af77b9d5b6f…d9bbb34c5368…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020793-001 CAFCIT CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 N020793-002 CAFCIT CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020793-001 AP
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 3 · 88 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 2026-10-15 13:18:30 2026-09 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2000-04-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL RLD 2000-04-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL RLD 2000-04-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020793-001 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1999-09-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020793-002 CAFCIT EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION / ORAL RLD 2000-04-12 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 53 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0641-6164-01 CAFCIT 3 mL in 1 VIAL INJECTION 3 17 0641-6164-10 CAFCIT 10 in 1 BOX INJECTION 10 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6164 CAFCIT (CAFFEINE CITRATE) INJECTION [HIKMA PHARMACEUTICALS USA INC.] 16 Legacy NDC, 2 package rows 20240606_f9feb925-e1b8-41bc-b9c5-89198f07c0e9.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 Units Marketing start Marketing end Sample Exclude flag Status 0641-6164-01 00641616401 3 mL in 1 VIAL 3 ml Historical 0641-6164-10 00641616410 10 VIAL in 1 BOX (0641-6164-10) > 3 mL in 1 VIAL (0641-6164-01) 10 vial 2008-11-04 0000-00-00 No No Current