POTASSIUM CITRATE
- Product NDC
- 16571-864
- 11-digit product format
- 165710864
- Labeler code
- 16571
- Product ID
- 16571-864_2e4e8acc-d3ad-4246-bd65-d95691896fc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- potassium citrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA077440
- Marketing category
- ANDA
- Marketing start
- 2024-12-15
- Substance
- POTASSIUM CITRATE
- Active strength
- 540 mg/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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- POTASSIUM CITRATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM CITRATE | 540 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EE90ONI6FF |
| Rxcui | 199376, 199381 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-864-01 | POTASSIUM CITRATE | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-864 | POTASSIUM CITRATE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] | 4 | Current NDC, 1 package rows | 20250215_164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-864-01 | 16571086401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-864-01) | 2024-12-15 | No | No | Current |