CAFCIT

Product NDC: 0641-6164
Requested package NDC: 0641-6164-10
11-digit product format: 006416164
Labeler code: 0641
Product ID: 0641-6164_a9ead4b9-ad44-4806-989a-02dd4f78dd3b
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: 2026-06-01
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
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0641-6164	0641-6164-10	D	Discontinued by firm		2026-08-17
excluded package	package	0641-6164	0641-6164-10	D	Discontinued by firm		2026-08-17

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 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	E	Excluded after deficient or non-compliant submission was not corrected	`8af77b9d5b6f…`	`d9bbb34c5368…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 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	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…`
2019-12-13 00:20 UTC	2019-12	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / ORAL	AA	RLD, RS	2000-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / ORAL		RLD	2000-04-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020793-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020793-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020793-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020793-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020793-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020793-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020793-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020793-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020793-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020793-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020793-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020793-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020793-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020793-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020793-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020793-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020793-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020793-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020793-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020793-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020793-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020793-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020793-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020793-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020793-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020793-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020793-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020793-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020793-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020793-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020793-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020793-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020793-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020793-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020793-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020793-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020793-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020793-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020793-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020793-001	AP	1	`ea1830bbd6c7…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6164-01	ML - Milliliter	0641-6164	a48d6a41-0f87-43b3-a175-3b38ba2dc2b8	1	2015-06-09
0641-6164-10	ML - Milliliter	0641-6164	f736b58f-d766-4aee-90ed-6afa8fb9a8ee	1	2015-06-09

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	Current NDC, 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caffeine Citrate	CAFFEINE CITRATE	Hikma Pharmaceuticals USA Inc.	21489401-f2a7-47d3-897a-4b7efa04dd7a	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020793 application number: NDA020793

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U26EO4675Q	CAFFEINE CITRATE	69-22-7	CAFFEINE CITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6164-10	00641616410	10 VIAL in 1 BOX (0641-6164-10) / 3 mL in 1 VIAL (0641-6164-01)	10 vial	2008-11-04	2026-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Caffeine Citrate Injection, USP	Hikma Pharmaceuticals USA Inc.	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	17