POTASSIUM CITRATE

Product NDC
42543-408
11-digit product format
425430408
Labeler code
42543
Product ID
42543-408_e9e76355-cc27-427b-a787-7628a4b88eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA206813
Marketing category
ANDA
Marketing start
2017-11-01
Substance
POTASSIUM CITRATE
Active strength
15 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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206813-001POTASSIUM CITRATEPOTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11
A206813-002POTASSIUM CITRATEPOTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11
A206813-003POTASSIUM CITRATEPOTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206813-001AB
A206813-002AB
A206813-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206813-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206813-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206813-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2017-09-111e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206813-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206813-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206813-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206813-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206813-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206813-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206813-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206813-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206813-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206813-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206813-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206813-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206813-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206813-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206813-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206813-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206813-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206813-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206813-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206813-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206813-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206813-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206813-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206813-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206813-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206813-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206813-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206813-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206813-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206813-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206813-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206813-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206813-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206813-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206813-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206813-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206813-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206813-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206813-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206813-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
POTASSIUM CITRATE
Brand name suffix
EXTENDED RELEASE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE15 meq/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EE90ONI6FFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199376Internal RxNorm lookup
199381Internal RxNorm lookup
898490Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f38b02c-703c-4fc2-b833-654e41bd617fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42543-408-01POTASSIUM CITRATEEXTENDED RELEASE100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-408-01EA - Each42543-4088b535d7b-f913-4baa-b914-893058893a2512017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-408POTASSIUM CITRATE EXTENDED RELEASE (POTASSIUM CITRATE) TABLET [STRIDES PHARMA INC.]9Current NDC, Legacy NDC, 1 package rows20230622_5f38b02c-703c-4fc2-b833-654e41bd617f.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack3dd9c9eb-df19-4ec9-bc77-f3a159b33d942025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206813
application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack44ab2c4f-4a76-470d-98fb-8874c692a9672025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206813
application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEStrides Pharma Inc.5f38b02c-703c-4fc2-b833-654e41bd617f2025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206813
application number: ANDA206813
ndc (product): 42543-408
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack8f5f7078-3c2d-406f-9222-b82a0f79d1682025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206813
application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepackb6ce81aa-ed9e-4eac-9f9c-26e2560f06db2025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206813
application number: ANDA206813
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack9774b7c5-4695-47c9-9eb8-e0af2e05f5c32024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206813
application number: ANDA206813

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490K+ citrate 15 MEQ Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490Pot citrate 15 MEQ Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
898490potassium citrate 1620 MG Extended Release Oral TabletSY8f5f7078-3c2d-406f-9222-b82a0f79d168102
199381potassium citrate 10 MEQ Extended Release Oral TabletPSN5f38b02c-703c-4fc2-b833-654e41bd617f10
898490potassium citrate 15 MEQ Extended Release Oral TabletPSN5f38b02c-703c-4fc2-b833-654e41bd617f10
199376potassium citrate 5 MEQ Extended Release Oral TabletPSN5f38b02c-703c-4fc2-b833-654e41bd617f10
199381potassium citrate 10 MEQ Extended Release Oral TabletSCD5f38b02c-703c-4fc2-b833-654e41bd617f10
898490potassium citrate 15 MEQ Extended Release Oral TabletSCD5f38b02c-703c-4fc2-b833-654e41bd617f10
199376potassium citrate 5 MEQ Extended Release Oral TabletSCD5f38b02c-703c-4fc2-b833-654e41bd617f10
199381K+ citrate 10 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
898490K+ citrate 15 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199376K+ citrate 5 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199381Pot citrate 10 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
898490Pot citrate 15 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199376Pot citrate 5 MEQ Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199381potassium citrate 1080 MG Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
898490potassium citrate 1620 MG Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10
199376potassium citrate 540 MG Extended Release Oral TabletSY5f38b02c-703c-4fc2-b833-654e41bd617f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42543-408-0142543040801100 TABLET in 1 BOTTLE (42543-408-01) 100 tablet2017-11-010000-00-00NoNoCurrent