Prescription drug · ANDA
Potassium Citrate Extended Release (Potassium citrate) NDC 72162-2478
Potassium citrate 15 meq/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2478-1 | 7216224780172162247801 | 100 TABLET in 1 BOTTLE (72162-2478-1)Marketed from May 1, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Potassium Citrate Extended ReleaseSuffix: EXTENDED RELEASE
- Generic name (nonproprietary)
- potassium citrate
- Active ingredients
- Potassium citrate — 15 meq/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206813
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 72162-2478_54d422f4-91ce-443a-b14a-5fc09fbe4b6dSPL ID 54d422f4-91ce-443a-b14a-5fc09fbe4b6dSPL set ID 8f5f7078-3c2d-406f-9222-b82a0f79d168RxCUI 898490UNII EE90ONI6FF
- Pharmacologic class
- Anti-coagulant; Calculi Dissolution Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472162247801followed by a unit qualifier and the quantityPackage 72162-2478-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Potassium citrate is a citrate salt of potassium indicated for the management of: • Renal tubular acidosis (RTA) with calcium stones (1.1) • Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) • Uric acid lithiasis with or without calcium stones (1.3) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)] . 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)] . 1.3 Uric Acid Llithiasis with or without Calcium Stones Potassium citra…
Excerpt only. Read the full label for complete information.
About NDC 72162-2478
- What is NDC 72162-2478?
- 72162-2478 is the product NDC for Potassium Citrate Extended Release, Potassium citrate 15 meq/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Potassium Citrate Extended Release (Potassium citrate).
- What is the active ingredient?
- Potassium citrate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 72162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Potassium Citrate Extended Release?
- 7 other product NDCs are listed under this name. See all Potassium Citrate Extended Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Potassium Citrate Extended Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 5 meq/1 | TabletOral | Strides Pharma Inc. | 42543-406 | 42543-0406-01 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Strides Pharma Inc. | 42543-407 | 42543-0407-01 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 15 meq/1 | TabletOral | Strides Pharma Inc. | 42543-408 | 42543-0408-01 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 71335-1706 | 71335-1706-01 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 71335-2871 | 71335-2871-01 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 5 meq/1 | TabletOral | Bryant Ranch Prepack | 72162-2476 | 72162-2476-01 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 72162-2477 | 72162-2477-01 |
Other NDCs under ANDA 206813
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 5 meq/1 | TabletOral | Strides Pharma Inc. | 42543-406 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Strides Pharma Inc. | 42543-407 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 15 meq/1 | TabletOral | Strides Pharma Inc. | 42543-408 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 71335-1706 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 71335-2871 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 5 meq/1 | TabletOral | Bryant Ranch Prepack | 72162-2476 |
| Potassium Citrate Extended Releasepotassium citrate | Potassium citrate 10 meq/1 | TabletOral | Bryant Ranch Prepack | 72162-2477 |