Potassium Citrate
- Product NDC
- 68382-536
- 11-digit product format
- 683820536
- Labeler code
- 68382
- Product ID
- 68382-536_b0382b88-fcc4-44de-b66d-a93dabc596f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Citrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA203546
- Marketing category
- ANDA
- Marketing start
- 2014-08-12
- Substance
- POTASSIUM CITRATE
- Active strength
- 5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Potassium Citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM CITRATE | 5 meq/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | EE90ONI6FF |
| Rxcui | 199376, 199381, 898490 |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68382-536-01 | Potassium Citrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 6 | |
| 68382-536-05 | Potassium Citrate | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 6 | |
| 68382-536-06 | Potassium Citrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 6 | |
| 68382-536-10 | Potassium Citrate | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | 6 | |
| 68382-536-16 | Potassium Citrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 6 | |
| 68382-536-30 | Potassium Citrate | 10 in 1 CARTON | TABLET, EXTENDED RELEASE | 10 | 6 | |
| 68382-536-30 | Potassium Citrate | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-536-01 | EA - Each | 68382-536 | e5681463-5f6c-4f58-8cc5-5cc951a4f36a | 1 | 2014-09-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| POTASSIUM CITRATE | ACTIVE INGREDIENT | EE90ONI6FF | POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 1 | |
| ANHYDROUS CITRIC ACID | ACTIVE MOIETY | XF417D3PSL | POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199381 | potassium citrate 10 MEQ Extended Release Oral Tablet | PSN | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 898490 | potassium citrate 15 MEQ Extended Release Oral Tablet | PSN | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199376 | potassium citrate 5 MEQ Extended Release Oral Tablet | PSN | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199381 | potassium citrate 10 MEQ Extended Release Oral Tablet | SCD | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 898490 | potassium citrate 15 MEQ Extended Release Oral Tablet | SCD | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199376 | potassium citrate 5 MEQ Extended Release Oral Tablet | SCD | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199381 | K+ citrate 10 MEQ Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 898490 | K+ citrate 15 MEQ Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199376 | K+ citrate 5 MEQ Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199381 | Pot citrate 10 MEQ Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 898490 | Pot citrate 15 MEQ Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199376 | Pot citrate 5 MEQ Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199381 | potassium citrate 1080 MG Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 898490 | potassium citrate 1620 MG Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199376 | potassium citrate 540 MG Extended Release Oral Tablet | SY | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 6 |
| 199381 | potassium citrate 10 MEQ Extended Release Oral Tablet | PSN | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 898490 | potassium citrate 15 MEQ Extended Release Oral Tablet | PSN | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199376 | potassium citrate 5 MEQ Extended Release Oral Tablet | PSN | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199381 | potassium citrate 10 MEQ Extended Release Oral Tablet | SCD | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 898490 | potassium citrate 15 MEQ Extended Release Oral Tablet | SCD | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199376 | potassium citrate 5 MEQ Extended Release Oral Tablet | SCD | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199381 | K+ citrate 10 MEQ Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 898490 | K+ citrate 15 MEQ Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199376 | K+ citrate 5 MEQ Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199381 | Pot citrate 10 MEQ Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 898490 | Pot citrate 15 MEQ Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199376 | Pot citrate 5 MEQ Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199381 | potassium citrate 1080 MG Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 898490 | potassium citrate 1620 MG Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
| 199376 | potassium citrate 540 MG Extended Release Oral Tablet | SY | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-536-01 | 68382053601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-01) | 2014-08-12 | 0000-00-00 | No | No | Current | |
| 68382-536-05 | 68382053605 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-05) | 2014-08-12 | 0000-00-00 | No | No | Current | |
| 68382-536-06 | 68382053606 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-06) | 2014-08-12 | 0000-00-00 | No | No | Current | |
| 68382-536-10 | 68382053610 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-10) | 2014-08-12 | 0000-00-00 | No | No | Current | |
| 68382-536-16 | 68382053616 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-16) | 2014-08-12 | 0000-00-00 | No | No | Current | |
| 68382-536-30 | 68382053630 | 10 BLISTER PACK in 1 CARTON (68382-536-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2014-08-12 | 0000-00-00 | No | No | Current |