Prescription drug · ANDA
Calcium Acetate NDC 82804-968
Calcium acetate 667 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-968-00 | 8280409680082804096800 | 100 CAPSULE in 1 BOTTLE (82804-968-00)Marketed from Jun 25, 2025 | |
| 82804-968-20 | 8280409682082804096820 | 20 CAPSULE in 1 BOTTLE (82804-968-20)Marketed from Jun 25, 2025 | |
| 82804-968-30 | 8280409683082804096830 | 30 CAPSULE in 1 BOTTLE (82804-968-30)Marketed from Jun 25, 2025 | |
| 82804-968-55 | 8280409685582804096855 | 500 CAPSULE in 1 BOTTLE (82804-968-55)Marketed from Jun 25, 2025 | |
| 82804-968-60 | 8280409686082804096860 | 60 CAPSULE in 1 BOTTLE (82804-968-60)Marketed from Jun 25, 2025 | |
| 82804-968-64 | 8280409686482804096864 | 240 CAPSULE in 1 BOTTLE (82804-968-64)Marketed from Jun 25, 2025 | |
| 82804-968-72 | 8280409687282804096872 | 120 CAPSULE in 1 BOTTLE (82804-968-72)Marketed from Jun 25, 2025 | |
| 82804-968-78 | 8280409687882804096878 | 180 CAPSULE in 1 BOTTLE (82804-968-78)Marketed from Jun 25, 2025 | |
| 82804-968-90 | 8280409689082804096890 | 90 CAPSULE in 1 BOTTLE (82804-968-90)Marketed from Jun 25, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Calcium Acetate
- Generic name (nonproprietary)
- calcium acetate
- Active ingredients
- Calcium acetate — 667 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203179
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 82804-968_80c15366-9420-41c2-8817-b9c39ddfcec1SPL ID 80c15366-9420-41c2-8817-b9c39ddfcec1SPL set ID 80c15366-9420-41c2-8817-b9c39ddfcec1RxCUI 359296UNII Y882YXF34XUPC 0382804968305
- Pharmacologic class
- Blood Coagulation Factor; Phosphate Binder
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
N482804096800followed by a unit qualifier and the quantityPackage 82804-0968-00. 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)
1. INDICATIONS & USAGE Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). • Calcium acetate capsules are a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 82804-968
- What is NDC 82804-968?
- 82804-968 is the product NDC for Calcium Acetate, Calcium acetate 667 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 9 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcium Acetate.
- What is the active ingredient?
- Calcium acetate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calcium Acetate?
- 21 other product NDCs are listed under this name. See all Calcium Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calcium Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | American Health Packaging | 60687-589 | 60687-0589-65 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | AvPAK | 50268-203 | 50268-0203-15 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-411 | 69367-0411-02 |
| calcium acetate | Calcium acetate 667 mg/1 | CapsuleOral | AvKARE | 73190-031 | 73190-0031-20 |
| calcium acetate | Calcium acetate 667 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4299 | 70518-4299-00 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8632 | 00615-8632-39 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-422 | 72789-0422-97 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Nivagen Pharmaceuticals, Inc. | 75834-323 | 75834-0323-02 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | SQUARE PHARMACEUTICALS LIMITED | 76483-086 | 76483-0086-00 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-813 | 16571-0813-20 |
Other NDCs under ANDA 203179
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 |
|---|---|---|---|---|
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | AvPAK | 50268-203 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-411 |