Prescription drug · ANDA
Calcium Acetate NDC 0054-0088
Calcium acetate 667 mg/1 · Capsule · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0088-13 | 00054008813 | 30 CAPSULE in 1 BOTTLE (0054-0088-13)Marketed from Feb 28, 2008 | |
| 0054-0088-26 | 00054008826 | 200 CAPSULE in 1 BOTTLE (0054-0088-26)Marketed from Feb 28, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077728
- 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 0054-0088_bd03f7bd-1e38-4419-a991-c7f39cee364dSPL ID bd03f7bd-1e38-4419-a991-c7f39cee364dSPL set ID 85fd41f8-2823-44ca-a15e-f1f2e5d0ff94RxCUI 359296UNII Y882YXF34X
- 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
N400054008813followed by a unit qualifier and the quantityPackage 00054-0088-13. 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)
Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). • Calcium acetate is 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.
Other NDCs under ANDA 077728
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 | Major Pharmaceuticals | 0904-7119 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-4169 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | American Health Packaging | 68084-479 |