Potassium Citrate and Citric Acid
- Product NDC
- 0121-0676
- 11-digit product format
- 001210676
- Labeler code
- 0121
- Product ID
- 0121-0676_a89c03e3-61a9-46df-9de7-e73f522f123d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Potassium Citrate and Citric Acid Monohydrate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 1997-10-07
- Substance
- CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE
- Active strength
- 334; 1100 mg/5mL; mg/5mL
- Pharmacologic classes
- Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], 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 and Citric Acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CITRIC ACID MONOHYDRATE | 334 mg/5mL |
| POTASSIUM CITRATE | 1100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2968PHW8QP, EE90ONI6FF |
| Rxcui | 309318 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0676-16 | Potassium Citrate and Citric Acid | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Citric Acid Monohydrate | ACTIVE INGREDIENT | 2968PHW8QP | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Potassium Citrate | ACTIVE INGREDIENT | EE90ONI6FF | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Anhydrous Citric Acid | ACTIVE MOIETY | XF417D3PSL | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0676 | POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241121_ce42122f-8087-471f-b0a3-5524bdbd4526.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-0676-16 | 00121067616 | 473 mL in 1 BOTTLE (0121-0676-16) | 473 ml | 1997-10-07 | 0000-00-00 | No | No | Current |