Cytra-K Crystals

Product NDC: 60258-005
11-digit product format: 602580005
Labeler code: 60258
Product ID: 60258-005_9625f8fc-b958-4054-9580-826d15156ba5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Citrate and Citric Acid
Dosage form: GRANULE, FOR SOLUTION
Route: ORAL
Labeler: Cypress Pharmaceutical, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2003-05-01
Marketing end: 0000-00-00
Substance: POTASSIUM CITRATE; CITRIC ACID MONOHYDRATE
Active strength: 3 g/1; g/1
Pharmacologic classes: Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 product	product	60258-005		I	Inactivated by FDA		2026-10-12
excluded package	package	60258-005	60258-005-01	I	Inactivated by FDA		2026-10-12

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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60258-005-01	I	Inactivated by FDA	`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	60258-005-01	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	60258-005-01	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	60258-005-01	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	60258-005-01	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	60258-005-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60258-005-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60258-005-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60258-005-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60258-005-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60258-005-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60258-005-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60258-005-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60258-005-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60258-005-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	60258-005-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	60258-005-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	60258-005-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	60258-005-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	60258-005-01	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	60258-005-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	60258-005-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60258-005-01	2020-01-31	C162847	48780-1	9d75b9cf-ea98-f424-e053-dadaa90a57ce	CYTRA-K CRYSTALS (Potassium Citrate and Citric Acid for Oral Solution)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60258-005-01	Cytra-K Crystals	100 in 1 BOX	GRANULE, FOR SOLUTION	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60258-005-01	EA - Each	60258-005	e30a9ee3-1186-4875-9b4b-714ca8733c43	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Citric Acid Monohydrate	ACTIVE INGREDIENT	2968PHW8QP	CYTRA-K CYSTRALS (POTASSIUM CITRATE AND CITRIC ACID ) GRANULE, FOR SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	1
Potassium Citrate	ACTIVE INGREDIENT	EE90ONI6FF	CYTRA-K CYSTRALS (POTASSIUM CITRATE AND CITRIC ACID ) GRANULE, FOR SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	1
Citric Acid	ACTIVE MOIETY	2968PHW8QP	CYTRA-K CYSTRALS (POTASSIUM CITRATE AND CITRIC ACID ) GRANULE, FOR SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	1
Potassium Cation	ACTIVE MOIETY	295O53K152	CYTRA-K CYSTRALS (POTASSIUM CITRATE AND CITRIC ACID ) GRANULE, FOR SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	1
Saccharin Sodium Anhydrous	INACTIVE INGREDIENT	I4807BK602	CYTRA-K CYSTRALS (POTASSIUM CITRATE AND CITRIC ACID ) GRANULE, FOR SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60258-005	CYTRA-K CRYSTALS (POTASSIUM CITRATE AND CITRIC ACID ) GRANULE, FOR SOLUTION [CYPRESS PHARMACEUTICAL, INC.]	3	Legacy NDC, 1 package rows	20160921_490c77d7-47f8-439f-aa37-953692f4c23a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EE90ONI6FF	POTASSIUM CITRATE	6100-05-6	POTASSIUM CITRATE
2968PHW8QP	CITRIC ACID MONOHYDRATE	5949-29-1	CITRIC ACID MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1652638	CYTRA-K CRYSTALS 3300 MG / 1002 MG Powder for Oral Solution	PSN	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652634	potassium citrate 3300 MG / citric acid 1002 MG Powder for Oral Solution	PSN	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652638	citric acid 1002 MG / potassium citrate 3300 MG Powder for Oral Solution [Cytra-K]	SBD	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652634	citric acid 1002 MG / potassium citrate 3300 MG Powder for Oral Solution	SCD	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652634	Citric Acid 1002 MG / K+ citrate 3300 MG Powder for Oral Solution	SY	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652638	Citric Acid 1002 MG / K+ citrate 3300 MG Powder for Oral Solution [Cytra-K]	SY	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652634	Citric Acid 1002 MG / Pot citrate 3300 MG Powder for Oral Solution	SY	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652638	Citric Acid 1002 MG / Pot citrate 3300 MG Powder for Oral Solution [Cytra-K]	SY	490c77d7-47f8-439f-aa37-953692f4c23a	3
1652638	Cytra-K (citric acid 1002 MG / potassium citrate 3300 MG) Powder for Oral Solution	SY	490c77d7-47f8-439f-aa37-953692f4c23a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
60258-005-01	60258000501	100 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYTRA-K CRYSTALS (Potassium Citrate and Citric Acid for Oral Solution)	Cypress Pharmaceutical, Inc. \| Tower Laboratories Ltd	2016-09-20	HUMAN PRESCRIPTION DRUG LABEL	3