Home NDC 63629-8759 Potassium Citrate
Product NDC 63629-8759
11-digit product format 636298759
Labeler code 63629
Product ID 63629-8759_3af62a61-a384-4f52-aa75-6419fea90b54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Citrate
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA209758
Marketing category ANDA
Marketing start 2018-05-30
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 1 .
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 RLD / RS Approval date A209758-001 POTASSIUM CITRATE POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE / ORAL AB 2018-03-05 A209758-002 POTASSIUM CITRATE POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE / ORAL AB 2018-03-05 A209758-003 POTASSIUM CITRATE POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE / ORAL AB 2018-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
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 2026-08-01 22:54:32 2026-06 A209758-001 POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE / ORAL AB 2018-03-05 a50c72e98297…2026-08-01 22:54:32 2026-06 A209758-002 POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE / ORAL AB 2018-03-05 a50c72e98297…2026-08-01 22:54:32 2026-06 A209758-003 POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE / ORAL AB 2018-03-05 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8759-1 Potassium Citrate 100 in 1 BOTTLE TABLET, EXTENDED RELEASE 100 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8759 POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 1 package rows 20240112_4af19ffc-80e1-4182-bccf-e7abb1bf457c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-8759-1 63629875901 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8759-1) 2022-08-25 0000-00-00 No No Current