IDkit HP ONE

Product NDC: 50402-100
11-digit product format: 504020100
Labeler code: 50402
Product ID: 50402-100_76ea9288-076c-4e3b-930c-5653181aaaef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: citric acid anhydrous and 13C urea
Dosage form: SOLUTION
Route: ORAL
Labeler: Meridian Bioscience Israel Ltd
Application: NDA021314
Marketing category: NDA
Marketing start: 2009-12-28
Substance: UREA C-13; CITRIC ACID MONOHYDRATE
Active strength: 75; 4 mg/1; g/1
Pharmacologic classes: Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carbon Radioisotopes [CS], Decreased Coagulation Factor Activity [PE], Helicobacter pylori Diagnostic [EPC], Radioactive Tracers [CS], Urea [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50402-100-14	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50402-100-13	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50402-100-14	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50402-100-13	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50402-100-14	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50402-100-13	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50402-100-11	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50402-100-22	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021314-001	IDKIT:HP	CITRIC ACID; UREA C-13	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL		RLD, RS	2002-12-17

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021314-001	IDKIT:HP	N/A,4GM;75MG,N/A	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021314-001	IDKIT:HP	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION / ORAL	RLD, RS	2002-12-17	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: IDkit HP ONE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UREA C-13	75 mg/1
CITRIC ACID MONOHYDRATE	4 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W6KX9E6D8X	Internal UNII lookup
2968PHW8QP	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8baab7a7-5d20-46ad-9c4a-762992ef6b51	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50402-100-13	2023-09-15	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-13	2023-09-15	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002
50402-100-14	2023-09-15	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-14	2023-09-15	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002
50402-100-13	2022-01-28	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-13	2022-01-28	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002
50402-100-14	2022-01-28	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-14	2022-01-28	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002
50402-100-11	2020-01-02	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-11	2020-01-02	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002
50402-100-22	2020-01-02	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-22	2020-01-02	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002
50402-100-11	2019-10-29	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-11	2019-10-29	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002
50402-100-22	2019-10-29	8baab7a7-5d20-46ad-9c4a-762992ef6b51
50402-100-22	2019-10-29	These highlights do not include all the information needed to use IDKIT HP ® ONE AND IDKIT HP ® TWO safely and effectively. See full prescribing information for IDKIT HP ® ONE AND IDKIT HP ® TWO. IDKIT HP ® One ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP ® Two ( 13 C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50402-100-13	IDkit HP ONE	25 in 1 BOX	SOLUTION	25	5
50402-100-13	IDkit HP ONE	1 in 1 BAG	SOLUTION	1	5
50402-100-14	IDkit HP ONE	5 in 1 CASE	SOLUTION	5	5
50402-100-14	IDkit HP ONE	1 in 1 BOX	SOLUTION	1	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
citric acid	ACTIVE INGREDIENT	2968PHW8QP	IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) KIT [EXALENZ BIOSCIENCE LTD.]	1
urea c-13	ACTIVE INGREDIENT	W6KX9E6D8X	IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) KIT [EXALENZ BIOSCIENCE LTD.]	1
citric acid	ACTIVE MOIETY	2968PHW8QP	IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) KIT [EXALENZ BIOSCIENCE LTD.]	1
urea c-13	ACTIVE MOIETY	W6KX9E6D8X	IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) KIT [EXALENZ BIOSCIENCE LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50402-100	IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) SOLUTION [MERIDIAN BIOSCIENCE ISRAEL LTD]	5	Current NDC, Legacy NDC, 4 package rows	20250131_8baab7a7-5d20-46ad-9c4a-762992ef6b51.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
IDkit HP ONE	CITRIC ACID ANHYDROUS AND 13C UREA	Meridian Bioscience Israel Ltd	8baab7a7-5d20-46ad-9c4a-762992ef6b51	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021314 application number: NDA021314 ndc (product): 50402-100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W6KX9E6D8X	UREA C-13	58069-82-2	UREA C-13
2968PHW8QP	CITRIC ACID MONOHYDRATE	5949-29-1	CITRIC ACID MONOHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50402-100-13	50402010013	25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG	25 bag	2013-05-01	0000-00-00	No	No	Current
50402-100-14	50402010014	5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX	5 box	2017-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IDkit HP ONE	Meridian Bioscience Israel Ltd \| Taro Pharmaceutical Industries Ltd.	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	6