Potassium Citrate
- Product NDC
- 44523-415
- 11-digit product format
- 445230415
- Labeler code
- 44523
- Product ID
- 44523-415_461546fa-70f8-dad0-e063-6394a90a4675
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- potassium citrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Biocomp Pharma, Inc.
- Application
- NDA019071
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-12-23
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019071-001 | UROCIT-K | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 |
| N019071-002 | UROCIT-K | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 |
| N019071-003 | UROCIT-K | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019071-001 | AB |
| N019071-002 | AB |
| N019071-003 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019071-002 | UROCIT-K | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1992-08-31 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019071-003 | UROCIT-K | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-12-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019071-001 | UROCIT-K | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1985-08-30 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019071-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019071-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019071-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019071-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019071-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019071-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019071-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019071-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019071-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019071-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019071-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019071-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019071-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019071-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019071-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019071-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019071-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019071-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019071-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019071-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019071-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019071-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019071-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019071-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019071-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019071-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019071-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019071-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019071-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019071-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019071-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019071-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019071-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019071-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019071-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019071-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019071-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019071-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019071-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019071-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Potassium Citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM CITRATE | 15 meq/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| EE90ONI6FF | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44523-415-01 | Potassium Citrate | 100 in 1 BOTTLE | TABLET | 100 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 44523-415-01 | EA - Each | 44523-415 | ba7f3221-9b46-46b3-adb1-35bdea3b445f | 1 | 2014-01-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| POTASSIUM CITRATE | ACTIVE INGREDIENT | EE90ONI6FF | POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| ANHYDROUS CITRIC ACID | ACTIVE MOIETY | XF417D3PSL | POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| Carnauba Wax | INACTIVE INGREDIENT | R12CBM0EIZ | POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Potassium Citrate | POTASSIUM CITRATE | Biocomp Pharma, Inc. | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 2025-12-16 | Warnings, Adverse reactions | 019071 NDA019071 44523-415 |
| Potassium Citrate | POTASSIUM CITRATE | Upsher-Smith Laboratories, LLC | 2215dc1d-0b5a-469e-9b51-4d7480a51078 | 2025-07-14 | Warnings, Adverse reactions | 019071 NDA019071 |
| UROCIT-K | POTASSIUM CITRATE | Mission Pharmacal Company | 72cdea1b-2240-41db-987d-86d5c6aaa978 | 2021-12-02 | Warnings, Adverse reactions | 019071 NDA019071 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199381 | potassium citrate 10 MEQ Extended Release Oral Tablet | PSN | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 898490 | potassium citrate 15 MEQ Extended Release Oral Tablet | PSN | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 199381 | potassium citrate 10 MEQ Extended Release Oral Tablet | SCD | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 898490 | potassium citrate 15 MEQ Extended Release Oral Tablet | SCD | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 199381 | K+ citrate 10 MEQ Extended Release Oral Tablet | SY | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 898490 | K+ citrate 15 MEQ Extended Release Oral Tablet | SY | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 199381 | Pot citrate 10 MEQ Extended Release Oral Tablet | SY | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 898490 | Pot citrate 15 MEQ Extended Release Oral Tablet | SY | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 199381 | potassium citrate 1080 MG Extended Release Oral Tablet | SY | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
| 898490 | potassium citrate 1620 MG Extended Release Oral Tablet | SY | b32fe71a-4a58-04a1-64d3-bc3cc4a895bf | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 44523-415-01 | 44523041501 | 100 TABLET in 1 BOTTLE (44523-415-01) | 100 tablet | 2013-12-23 | 0000-00-00 | No | No | Current |