Potassium Citrate

Product NDC: 68084-850
11-digit product format: 680840850
Labeler code: 68084
Product ID: 68084-850_213c9f49-5d37-f84f-e063-6394a90aa698
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA203546
Marketing category: ANDA
Marketing start: 2014-11-12
Substance: POTASSIUM CITRATE
Active strength: 10 meq/1
Pharmacologic classes: Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203546-001	POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06
A203546-002	POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06
A203546-003	POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203546-001	AB
A203546-002	AB
A203546-003	AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-003	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203546-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2014-08-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A203546-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203546-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203546-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203546-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203546-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203546-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203546-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203546-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203546-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203546-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203546-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203546-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203546-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203546-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203546-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203546-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203546-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203546-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Citrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CITRATE	10 meq/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EE90ONI6FF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199381	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1201c777-2388-4235-bb8f-eb7dc1e867f8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-850-32	Potassium Citrate	20 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	20		6
68084-850-33	Potassium Citrate	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-850-32	EA - Each	68084-850	2d5ade25-88ae-4904-961a-35ed3819ae1c	1	2014-11-05
68084-850-33	EA - Each	68084-850	eed1def1-0d4f-4297-91da-f495abad7c9d	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM CITRATE	ACTIVE INGREDIENT	EE90ONI6FF	POTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
ANHYDROUS CITRIC ACID	ACTIVE MOIETY	XF417D3PSL	POTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	POTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	POTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-850	POTASSIUM CITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6	Current NDC, Legacy NDC, 2 package rows	20240905_1201c777-2388-4235-bb8f-eb7dc1e867f8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Citrate	POTASSIUM CITRATE	American Health Packaging	1201c777-2388-4235-bb8f-eb7dc1e867f8	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546 ndc (product): 68084-850
Potassium Citrate	POTASSIUM CITRATE	Golden State Medical Supply, Inc.	cb09c63d-f3f0-5d6b-e053-2995a90acd44	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546
Potassium Citrate	POTASSIUM CITRATE	Zydus Lifesciences Limited	39f46084-fc4b-4bfc-91cb-9be7e647655a	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546
Potassium Citrate	POTASSIUM CITRATE	Zydus Pharmaceuticals (USA) Inc.	1a839f91-9bbd-4f46-b350-c5e8074b5db7	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203546 application number: ANDA203546

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EE90ONI6FF	POTASSIUM CITRATE	6100-05-6	POTASSIUM CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	PSN	1201c777-2388-4235-bb8f-eb7dc1e867f8	6
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	SCD	1201c777-2388-4235-bb8f-eb7dc1e867f8	6
199381	K+ citrate 10 MEQ Extended Release Oral Tablet	SY	1201c777-2388-4235-bb8f-eb7dc1e867f8	6
199381	Pot citrate 10 MEQ Extended Release Oral Tablet	SY	1201c777-2388-4235-bb8f-eb7dc1e867f8	6
199381	potassium citrate 1080 MG Extended Release Oral Tablet	SY	1201c777-2388-4235-bb8f-eb7dc1e867f8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-850-32	68084085032	20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-850-32) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-850-33)	20 blister pack	2014-11-12	0000-00-00	No	No	Current
68084-850-33	68084085033	1 in 1 BLISTER PACK						Historical